Baxter Heparin Recall and Other Heparin News

Heparin manufacturer faces trial challenges

2010-08-28T07:23:00.000-07:00

According to an article in the Wall Street Journal, Baxter International Inc., maker of heparin, is facing challenges about disclosure regarding the 2008 heparin contamination debacle.

The crux of the matter has to do with revealing the Chinese supply chain during the depositions. Baxter's competitors who are seeking FDA approval for a newer more expensive kind of blood thinner want otherwise.

The Chinese contamination crisis was linked to 81 heparin deaths in the U.S. in 2008.

Baxter has denied negligence in the deaths linked to heparin.

preservative free heparin approved for infants

2010-07-13T20:04:00.000-07:00

The FDA approved a preservative-free Heparin Lock Flush Solution as a safer alternative for intravenous injection devices used in neonates and pediatric patients. The preservative-free Heparin is manufactured by APP Pharmaceuticals, Inc.

Benzyl alcohol, a preservative that is currently used in multiple-dose vial preparations of Heparin Lock Flush Solution, has been associated with toxicity in neonates and has been reported to be associated with a fetal Gasping Syndrome in premature infants

Both the FDA, in concurrence with the American Academy of Pediatrics and the Centers for Disease Control and Prevention, recommends not using intravascular flush solutions containing benzyl alcohol for newborns.

The doses strengths are 10 UPS Units/1 mL and 100 USP Units/1 mL.

Heparin Deaths vs. Rat Vomit, Which is Worse?

2009-01-30T22:00:00.000-08:00

Ugh. I don’t which is worse.

Pfizer has a commercial warning consumers not to buy drugs from websites because the ingredients are unknown. Scary? Yes.

But what about real mega-million deep-pockets pharmaceutical companies whose main ingredients come from China and other non-English speaking countries and they still don’t know what or how these main ingredients are made?

This is not fiction. Heparin, the blood thinner, was made from adulterated heparin produced in unregulated Chinese factories.

So far 103 victims have died from the heparin crisis and Baxter is being sued for consumer fraud.

Maybe vomiting up a rat isn’t so bad if you’re still standing when it’s over?

The FDA cannot even regulate Georgia made peanut butter. How can they regulate China?

Heparin: What are the safer alternatives?

2008-12-26T01:45:00.000-08:00

In terms of anticoagulants, Heparin has literally ruled the roost for over 70 years, being the most popularly prescribed drug used in hospitals. In 2007, the medical world received a jolt when the product was recalled due to contamination. Since then, allegations and reports have been surfacing about the FDA's failure to inspect the pharmaceutical plant set-up in China. There have also been 785 serious injuries and 81 deaths as a result of the contaminated drug.

Naturally many people are now looking for an alternative to Heparin. The good news is that researchers are already on the job. After all, the increase in an elderly population as well as vascular intervention means that there should be more anticoagulants available in the market.

Lepirudin is one such alternative which has proven to be effective in treating patients with HAAb. It was also approved by the FDA for the treatment of HIT, though it has also proven to be effective in renal replacement therapy and cardiopulmonary bypass surgery.

Warfarin Sodium is an anticoagulant that can be taken orally but it has a number of risks, including hemorrhaging at certain concentrations. It also requires frequent monitoring. Another oral alternative is Ximelagatran which seemed to be very effective but has since been withdrawn due to issues with toxicity. Researchers are currently looking into direct thrombin inhibition as a method of anticoagulation. In any case, it is just a matter of time before an alternative is found.

Hopefully, patients won't have to deal with issues like the Heparin fiasco in future.

Study Confirms Contaminated Heparin Problem

2008-12-12T09:52:00.000-08:00

The New England Journal of Medicine (NEJM) recently published an article about a study done by Centers for Disease Control and Prevention (CDC) that the heparin recall was justified as it was contaminated with oversulfated chondroitin sulfate (OSCS).

The study focuses on more than 150 adverse reactions to the contaminated heparin. The adverse reactions included shortness of breath, hypotension, and nausea and happened within 30 minutes of taking the heparin.

If you or a loved one have experienced adverse side effects or died from contaminated heparin, contact a wrongful death lawyer immediately before the statute of limitations run out.

FDA Seizes More Heparin

2008-11-29T13:57:00.000-08:00

November 6, 2008—The FDA seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

Five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized by U.S. Marshals. The seized products were manufactured from material imported from China and were contaminated with over-sulfated chondroitin sulfate, a cheaper substance that mimics heparin's anticoagulant activity.

Heparin is a blood-thinning drug. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.

Over-sulfated chondroitin sulfate has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products with the cheap substitute.

The FDA has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.

The FDA informed Celsus Laboratories twice that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall.

Tainted Heparin Recalls Spurs FDA in China

2008-11-23T20:40:00.000-08:00

Earlier this year, the FDA discovered that contaminated heparin, a blood thinner manufactured in China, had been linked to dozens of deaths. The heparin was laced with a contaminant that mimics real heparin. Several Toledo residents filed wrongful death lawsuits.

Other problems with food and drugs imported from China included pet food, milk products, candy, pet food, and toys with lead. Is China trying to poison us?

What is way overdue but finally happened is that the FDA opened its first office in Beijing after all this contamination. Much more stringent oversight is needed.

More FDA offices will open in Guangzhou and Shanghai plus subsequent locations will include India, the Middle East, Latin America and Europe. FDA employees would inspect products and develop liaisons with Chinese officials and groups.

Heparin and the China Connection

2008-10-28T13:32:00.000-07:00

The pharmaceutical company Baxter International was recently forced to recall Heparin.

This drug, which is used as a blood-thinner, has already gained quite a degree of infamy. It has been linked with a number of overdose cases in infants, several of which have ended in death.

The most famous of these cases involved the children of Hollywood actor Dennis Quaid. Now reports are surfacing about the conditions in which this drug was made. Sources claim that Heparin was manufactured in China, in a factory which US regulators have recently labeled as having objectionable conditions.

While the FDA is currently investigating, they are still unclear as to whether the Chinese plant is the true source of the problems or not. But perhaps more disturbing is that the FDA didn't inspect the plant at all, even before granting the approval. Why? They mixed up the company name with another one.

The FDA is currently looking into a total of 448 cases related to this troublesome drug Heparin. However, only 215 of these cases have been listed as events of interest. In order to avoid a shortage of blood-thinner in the market, APP Pharmaceuticals has increased the production in order to meet the market needs.

Baxter International seems to have landed in hot water in some other areas as well: A number of violations were found at the company's plant in Puerto Rico, including inadequate testing of irradiation equipment. Baxter has already agreed to pay a fine of $15,000.

Heparin and the Hollywood Connection

2008-10-21T13:27:00.000-07:00

Heparin is an anti-coagulant drug often administered to newborn babies in order to prevent clotting in both the body and the IV lines.

Heparin gained notoriety for the role it played in a number of overdose cases. In 2006, six children were given an overdose in Indiana and three of them didn't survive. In Texas, 17 premature babies overdosed as well.

The sobering truth is that Heparin overdose cases seem to have become quite commonplace.

Heparin gained heightened fame when actor Dennis Quaid sued Baxter Healthcare Corp. for negligence when his two babies were given a heparin overdose. They were given 1,000 times the amount they should have received. Luckily, they survived.

Who is to blame?

Some say that it's the drug manufacturer fault, since Heparin packaging is strikingly similar to that of another drug called Heplock. The similar labeling has caused many overdose issues, since both have similar vials with the same kind of coloring. At a glance, it is difficult to tell the two apart.

Others blame the hospital for negligence saying their staff was not trained adequately. The hospital has now taken preventive steps to ensure that this kind of error doesn't happen again.

Quaid used his celebrity status to help bring the Heparin matter to light. Though his experience with Heparin is not a unique one, it does show how lethal the problem really is.

The Trouble with Heparin

2008-10-13T16:09:00.000-07:00

Heparin has caused a major scare in the market

There are a number of problems inherent with taking the drug heparin. These problems are not minor. In fact, the problems associated with the drug present the potential for major side effects. Many people who have taken this blood thinner have felt serious adverse reactions. These reactions include dangerous situations as internal bleeding and even instances of fatalities. This is why the manufacturer Baxter is facing serious consequences in the form of civil actions. However, while it is definitely wise that anyone suffering from any adverse reactions should seek legal remedy it is also important to seek immediate medical help as well.

Even if you have not experienced any immediate adverse reactions to the drug, it is still wise to discuss the matter with your primary care doctor. Just because you may not feel any symptoms from the drug, this does not mean severe negative effects are not occurring. The only way to make sure that you are in perfect shape would be to have your doctor perform a proper examination. It’s important to inform the doctor of how much heparin you have taken and for how long.

Additionally, the level of the severity of the adverse reactions would play a huge role in a civil suit judgment. A doctor's report noting the serious adverse side effects a patient has suffered will surely be needed in court to make a case. Before even getting to this point, it is critical that a patient recover his/her good health. Doing so will aid in eliminating any further serious health dangers. Check with your doctor first and then take the necessary legal steps if needed. This would be the best course of action. Remember….it is health first and legal recourse regarding heparin immediately thereafter.

Reining in Heparin in Hospitals

2008-10-08T19:52:00.000-07:00

According to a regulatory group, hospitals must rein in heparin mistakes by using preventative measures of new bar code technology and computerized drug orders. Recent errors include overdoses to newborn infants including actor Dennis Quaid’s twins.

Now investigators will make surprise visits to ensure that hospitals are using the safety measures. Hospitals who fail will have their accreditation pulled.

The investigators are a private group that sets hospital standards and accredits hospitals and medical centers.

Almost 60,000 medication errors involving blood thinners were reported between 2001 and 2006.

Tainted Baxter Heparin Love

2008-10-01T20:43:00.000-07:00

The cause and effect of Baxter heparin is that three of ten patients tested positive for oversulfated chondroitin sulfate, the contaminant in Baxter heparin. Ten people died and the three of them were the result of a certain numbered lot of Baxter heparin. Heparin lot numbers were not known for the other seven patients

During the first quarter of 2008, 93 deaths were related to heparin.Baxter recalled the heparin products in February 2008 because of the spike in the number of the allergic reactions. It is believed that the oversulfated chondroitin sulfate was put intentionally in heparin by suppliers in China. Prior to this latest Baxter recall, the company received heparin's active ingredient from U.S. based Scientific Protein Laboratories. Heparin's active pharmaceutical ingredient is derived from pig intestines.

Earlier this year, the FDA tallied more than 90 reports of deaths and more than 1,000 adverse events associated with patients in the U.S. who had one or more allergic reactions to heparin products, including those sold by Baxter since Jan. 1, 2007. Clinical information is insufficient to specify the cause of death with clinical certainty.

Trouble with Heparin

2008-09-26T13:29:00.000-07:00

Heparin has caused a major scare in the marketplace

There are a number of problems inherent with taking the drug heparin. These problems are not minor. In fact, the problems associated with the drug present the potential for major side effects. Many people who have taken this blood thinner have felt serious adverse reactions. These reactions include dangerous situations as internal bleeding and even instances of fatalities. This is why the manufacturer Baxter is facing serious consequences in the form of civil actions. However, while it is definitely wise that anyone suffering from any adverse reactions should seek legal remedy it is also important to seek immediate medical help as well.

Even if you have not experienced any immediate adverse reactions to the drug, it is still wise to discuss the matter with your primary care doctor. Just because you may not feel any symptoms from the drug, this does not mean severe negative effects are not occurring. The only way to make sure that you are in perfect shape would be to have your doctor perform a proper examination. It’s important to inform the doctor of how much heparin you have taken and for how long.

Additionally, the level of the severity of the adverse reactions would play a huge role in a civil suit judgment. A doctor's report noting the serious adverse side effects a patient has suffered will surely be needed in court to make a case. Before even getting to this point, it is critical that a patient recover his/her good health. Doing so will aid in eliminating any further serious health dangers. Check with your doctor first and then take the necessary legal steps if needed. This would be the best course of action to employ bar none. Remember….it is health first and legal recourse regarding heparin immediately thereafter

heparin and kidney dialysis problems

2008-09-21T14:51:00.000-07:00

There are a number of problems heparin causes during kidney dialysis treatment.

It would be difficult to think of many more difficult medical situations to endure than kidney dialysis. To be blunt, kidney dialysis is used to save people's lives. Kidney dialysis is necessary when the kidneys are not functioning properly. Obviously, the kidneys are critical organs and if they do not function properly then there is the possibility for a life threatening scenario to develop. This is why kidney dialysis should not be made more complicated by the presence of other medical problems. As a result, other medications are brought into the picture to help stabilize the dialysis process. This is where heparin comes into play.

Heparin is an intravenous blood thinner used in conjunction with kidney dialysis. It is a major component in making sure the dialysis process works effectively. It’s nothing short of absolutely frightening when there is a problem with the drug. And, yes, a problem with the drug has developed. There have been a number of adverse reactions to heparin that range from severe allergic reactions to death as a result of taking heparin which has led to the FDA issuing a warning.

Issuing a warning hardly leaves the manufacturer, Baxter, off the hook for any adverse reactions deriving from heparin use. Nothing will absolve Baxter from any judgments from the heparin lawsuits that emerged in the aftermath of the warnings. The release of a dangerous drug is a very negligent action on the part of the manufacturer.

So, if you have suffered any adverse effects from taking heparin you may have a strong case for a lawsuit. That is why it is critical to discuss your options with a qualified attorney who can handle litigation against pharmaceutical companies. While these types of lawsuits are complex, they are not unwinnable as many huge judgments prove.

Heparin: How much is enough?

2008-09-17T02:34:00.000-07:00

According to the FDA, over one million doses of heparin were ingested by people who require use of the blood thinning medication. While one would assume that this would be a safe product since it is taken by so many people, the fact remains that this is a very dangerous drug. In fact, a number of fatalities have been reported. This is why a series of warnings has been issued by the FDA.

However, this brings about the question why is heparin such a dangerous product?

This question takes on a unique dimension when it is revealed heparin has been on the market for 70 years. Yes, you read that correctly. Heparin has been on the market for seven decades. How to the drug become so dangerous in only recent memory?

It is possible that there had been a number of problems with heparin in the past that have gone unnoticed, but this would be very unlikely. When you are talking about 70 years and millions of doses clearly a dangerous product would have revealed itself in the past.

Currently, the reasons behind the dangers of heparin are unknown and an investigation is under way. Hopefully, this investigation will reveal the reason why new product has become so harmful. From this, the ability to prevent such an incident from occurring in the future will be reduced.

At the present time, one needs to suffice with the cryptic warning as it is more important understand the clear and present danger as opposed to the reasons behind it.

Will the warnings of lawsuits associated with a heparin errode public confidence in the pharmaceutical companies? To a slim degree, it will. There, most people do realize that these types of problems are an anomaly and generally pharmaceutical drugs are safe and improve the quality of life.

FDA Investigating Heparin Drugs and More

2008-09-07T21:19:00.000-07:00

No Worries: FDA Investigating 20 Different Drugs Including Heparin

Leave it to the Food & Drug Administration to be investigating 20 different drugs for safety concerns but to not pull them off the market.

Nope, it's big business as usual. Keep taking them and building the fortunes of the pharmaceutical companies.

Heparin is one of those drugs as is Cymbalta for depression and a type of insulin among others.

Recommendations are to continue to take the drug and do not stop abruptly unless under a doctor's care. Your doctor should help you weigh the risks against the benefits.

Heparin: Purposeful Poisoning or Accidental?

2008-08-24T21:45:00.000-07:00

Was the latest heparin blood thinner debacle purposeful or an accident?

Usually conservative in opinion, the FDA commissioner told a Senate subcommittee that the heparin contamination was an economic fraud. The heparin contaminant of oversulfated chondroitin sulfate costs $9 a pound compared with $900 a pound for the active ingredient heparin.

Contaminated heparin-induced 81 deaths is being compared to cyanide laced Tylenol. However, with the blood thinner heparin there were far more deaths including a 60ish man in Ohio who lost both his wife and his son because they both suffered from the same genetic kidney disease that required constant dialysis.

The FDA has identified Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin. Chinese officials dispute the FDA that the contaminant caused injuries and death.

The FDA failed to inspect the plant as did Changzhou SPL. The FDA claims they don't have the budget to properly inspect all the foreign drug inspections.

Nobody wants to get tapped on the shoulder with heparin death blame. So what else is new? Who's minding the store?

Heparin Debaucle and the FDA

2008-08-23T12:30:00.000-07:00

When there is a drug or food blunder in another country, that country reacts and immediately recalls the offensive product. The same cannot be said about the FDA and the United States. The FDA doesn't have the power to do so but can only recommend a recall or black box warning label which usually takes months to implement.

In the meantime more people are seriously and fatally affected.

Like in the case of the blood thinner heparin -- In the Heparin debacle, the FDA reported that since the end of 2007, it received over 700 reports of adverse side effects associated with Baxter’s multiple-dose injectable Heparin; 40 percent of these reports were deemed serious.
There were inadequate FDA inspections of overseeing the active ingredients obtained from unregulated factories in China.

In the meantime, the FDA executives are giving themselves huge pay raises while there is no money in the budget to effectively monitor and investigate imports from other countries or hire more employees.

Heparin Testing Goes Awry?

2008-08-18T09:35:00.000-07:00

Did flawed heparin tests lead to the recall?

If the primary purpose of heparin it is to make life better for those who take it why did the drug turn out to be so dangerous? Wouldn't the manufacturer, Baxter, realize that releasing a dangerous drug into the marketplace would cause so many problems? Honestly, Baxter did not release purposefully release a dangerous drug in the marketplace. However, the release of the drug heparin was seriously flawed due to improper lab testing. This places a great deal of negligence on Baxter's shoulders.

Let's look at the situation more closely…

When numerous adverse side effects started to display themselves in patients who had been taking heparin, the FDA conducted an examination of the drug to ascertain the problem. As it turned out, the drug contained a dangerous contaminant. It was this contaminant that was the reason a great many people were suffering serious adverse side effects. And, needless to say, this was the reason the drug was pulled off the market. Proper testing of the product would have revealed this contaminant, but the tests conducted were weak. Now, while it was not Baxter's intention to release a dangerous product to the public this is exactly what the company did. Of course, this is also why the company is being held liable for the damages that have resulted in the aftermath of the release.

It is the responsibility of all pharmaceutical companies to make sure that any products that are released to the marketplace are safe for consumers. Often, consumers rely on these products for their very lives. This is why it is important that the product itself does not threaten the life of the person taking it. Yet, this is exactly the problem with heparin. Baxter was responsible for properly conducting tests to make sure this was a safe drug. Obviously, this is not the procedure the company followed and this is why Baxter is in the position it finds itself in right now.

Safer Synthetic Alternative to Contaminated Heparin

2008-08-17T18:48:00.000-07:00

The main source for heparin is the intestines of foreign livestock.

Disgusting!

The intestines of foreign livestock creates a condition that is wide open for mass contamination which recently happened in the latest China heparin catastrophe.

A team at the University of North Carolina developed synthetic heparin in 2006 and has worked since that time to fine tune a safer and better version of the blood thinner heparin. Oddly, the backbone for the new heparin comes from the bacteria found in e.coli which is easier to produce.

Through a proprietary scientific process it will probably take around five years to produce the demand required and go through clinical trials.

Better living with chemistry.

Good news, bad news, raw material, heparin

2008-08-13T11:12:00.000-07:00

In a global economy, there is both good news and bad news.

The good news is the possibility to increase economies of scale as well as breaking down barriers allowing companies to benefit from the largest and cheapest workforces, raw materials, and technology.

That's also the bad news.

Where's the quality control? Who's minding the store and the regulatory problems?

A perfect example is heparin.

The active ingredient is made in China without any regulatory oversight. The US Federal Drug Administration (FDA) doesn't have a handle on it and neither does its Chinese equivalent.

More than 50 percent of drug active ingredients are produced in China and India. Who's paying attention?

In regard to heparin, the FDA admitted to insufficient inspection of an American-owned production facility in China, prior to approving the drug for market.

On the good news side, a permanent FDA office is scheduled to open in China by October 2008 and pharmaceutical manufacturers there will be subjected to stricter scrutiny.

What about India?

Unfortunately, it's too late for the people who have already died from heparin.

Heparin – Class Action or Go It Alone?

2008-08-09T09:32:00.000-07:00

Is a class action heparin suit better than a "solo" suit?

If you have suffered as a result of taking heparin, you may be thinking of taking legal action. This is understandable because may of the severe consequences of taking this drug are the result of negligence on the part of the manufacturer. The manufacturer, Baxter, truly did not properly test and produce this potentially hazardous blood thinner. This is why there are a number of suits pending against Baxter. Those currently looking to file suit, however, many not be sure of what type of suit to file

That is, they may not know whether or not to file an action on their own or to take part in a class action lawsuit. For those not familiar with the term, a class action lawsuit is essentially a collective action were the multitude of people act as the plaintiffs in the suit. If a heparin settlement or judgment is arrived the monetary award would be the split among the various plaintiffs.

This, of course, brings about the question as to what would be the best course of action to take, filing a solo or class action suit. Honestly, this is not a question that can be answered with absolutism because each litigant's situation is different. Different needs and personal situations will dictate the proper course of action to take. So, in order to arrive at a decision, it would be best to consult with an attorney. In such a meeting, the various positives and negatives of class action vs. solo suits can be discussed.

They may be better served with an individual suit. Ultimately, the client needs to realize what would be the right action to take and careful deliberation with an attorney will aid in this regard.

FDA questions labeling of blood drug therapy

2008-08-08T13:13:00.000-07:00

Tainted Heparin, a blood thinner medication, manufactured by Baxter International has been directly linked to the deaths of three people as reported previously on this Baxter heparin recall blog.

Most recently, the FDA criticized Baxter International for misleading doctors about FEIBA VH's safety. FEIBA VH is a bleeding treatment drug therapy for people with hemophilia.

The FDA criticized the statement:

"FEIBA is well tolerated in 96%-100% of infusions with a low thrombotic event incidence (0.008%)"

According to the FDA, this is exaggerated.

The FDA requested that Baxter immediately cease the dissemination of the offending email letter as well as any same as or similar violative promotional materials for FEIBA VH.

Death by Heparin: The Responsibility Lies With...

2008-07-30T13:40:00.000-07:00

According to an article in the Chicago Tribune, the FDA conclusively linked patients deaths to specific lots of Baxter International heparin.

Of 10 deaths from severe hypotensive shock, three were traced to lot numbers of Baxter products that tested positive for oversulfated chondroitin sulfate.

Baxter recalled its heparin products in February when the number of allergic reactions spiked. Health officials and Baxter believe that the contaminated heparin was done intentionally by Chinese suppliers.

Chinese health officials continue to question whether the problems may have originated elsewhere. The Chinese maintain the problems did not originate with active ingredient sourced in China despite analysis by FDA, Baxter and outside experts.

93 people died in a short three month period; that's one a day. The FDA needs to continue investigating why. The families deserve to know.

If your loved one has died because of heparin tragedy, please contact Anapol Schwartz, a Pennsylvania personal injury law firm.

Hunt for Heparin Continues

2008-07-29T13:59:00.000-07:00

Calling all nurses!

The Georgia Association of Nurse Anesthesists (GANA) put out a FDA alert asking nursing professionals to be on the lookout for the continued use of oversulfated chondroitin sulfate contaminated heparin products.

And to report any adverse heparin related side effects.

Despite all the heparin recalls, the FDA believes that some heparin blood thinner products are still in use. Health professionals are urged to check out drug storage areas, emergency kits, and dialysis units.

Please educate yourself and other nurses about the problems associated with heparin usage.

The Herparin Recall

2008-07-29T09:22:00.000-07:00

A look into the Heparin recall is provided.

The Food and Drug Administration does not issue recalls without cause. This is because there are a number of problems inherent with issuing a recall flippantly. For example, issuing a recall can lead to a great deal of panic in the marketplace. This panic can seriously undermine the public's confidence in the safety of drugs. However, in the case of heparin, a recall was unavoidable.

It is not the goal of the FDA to scare people into believing that their medications are not safe unless sufficient cause is warranted. When a clear danger is present, however, the Food and Drug Administration will be quick to act in order to maintain a desired level of safety in the pharmacy world. Such was the case with Baxter's Heparin which turned out to be a product that was far less safe than what was originally believed.

The original intent of the drug was to act as a blood thinner. Unfortunately, there were a number of serious side effects associated with the use of this drug. These were not minor side effects as instances of serious injury and even death were reported. Of course, this led to many wondering how such flaws could be present in the medication. Eventually, it was revealed the actual physical production of the drug took place in China. As many news reports have shown, China is not exactly a country that puts much emphasis on the safety of its products. Such negligence found it's was into the process of producing heparin. But, regardless of where the drug was produced it is Baxter's responsibility to make sure that it is releasing a safe product in the market. Baxter failed in this regard and that is why it is facing the consequences of such non-action.

Currently, Baxter is facing a number of civil suits as a result of the heparin fiasco. While these suits can not change the past they can make sure that the future releases of such drugs are not rife with such serious problems. Hopefully, those who have filed suit will receive just compensation for the mishaps they have had to endure.

Probe continues in infants heparin overdose

2008-07-27T21:21:00.000-07:00

Medical and pharmaceutical personnel are being deposed in the case of families whose newborns received overdoses at a Corpus Christi hospital.

Temporary restraining orders were also extended in order to preserve medical records related to the two sets of twins who were among the 17 newborns receiving the overdoses of the blood thinner heparin.

An agreement was reached that the hospital would release to the plaintiffs samples of the batch of heparin given to the newborns.

The plaintiffs sought the temporary injunction to find out information about the drug's manufacturer.

Twins born July 1 died in July. For twins born June 16, one newborn died and the other remains in neonatal ICU.

Heparin tragedy and infants death

2008-07-22T21:05:00.000-07:00

Infant twins die from alleged heparin overdose.

If there are not already enough potential problems having to do with birthing, a Corpus Christi hospital mistakenly gave 17 babies an overdose of heparin.

Deja vu?

You probably saw the actor Dennis Quaid on talk shows a few months back talking about how his twins received 1,000 times the normal heparin dose. Quaid says his twins have since recovered their near death experience.

Why are bad things about heparin still happening?

Hospital staff was not aware of the error until receiving abnormal test results. The pediatric version of heparin was used to flush IV tubes to prevent blood clots from forming.

How this fatal incident occurred is still unknown but being investigated. Other conclusions could be the various confusing concentrations of available doses. Clearly staff is not paying attention whether they are understaffed, overworked, tired, or inexperienced.

Baxter Heparin Recalls – Heparin - Baxter Heparin

2008-07-12T07:41:00.000-07:00

For those of you who have been following the news related to the Baxter Heparin recalls and allergies, you will already know that the FDA has warned doctors to stop using Baxter’s heparin.

Baxter - Heparin Fiasco - Whose Fault
For those of you who have been following the news related to the Baxter Heparin recalls and allergies, you will already know that the FDA has warned doctors to stop using Baxter’s heparin. Baxter’s Heparin has been linked with at least 19 deaths and hundreds of people are currently suffering from life-threatening side effects of the drug.

Heparin is a life saving drug that acts as a blood thinner. It is used in surgery as it works quickly on the human body system. Baxter International manufactures more than 50% of the Heparin vials used in the US. In January 2008, there was an urgent recall of these Heparin vials as reports came pouring in about severe allergies caused by Baxter’s Heparin.

Investigations revealed that the FDA had not done an inspection of the Chinese plant that supplies the active ingredient for the heparin according to Baxter Heparin Luckily, the FDA has ensured that there is no shortage of the drug in the market by approaching other major supplier of heparin such as APP Pharmaceuticals. The cause for the adverse effects of Baxter’s heparin are still unknown.

Naturally, there is a spate of lawsuits from those who have suffered the adverse effects of Baxter’s heparin. The good news is that other drug manufacturers have now tightened their belts to make sure that all active ingredients from China undergo stringent quality checks. But, where does the buck stop for the Baxter Heparin tragedy? The FDA because they did not check the Chinese supplier or Baxter because they are being held responsible?

Baxter Heparin – Herpain - Recall Of Baxtrer Heparin

2008-07-08T07:39:00.000-07:00

The recall of Baxter Heparin has once again thrown open to debate the vital issue of drug safety. It is high time now that consumer protection agencies worldwide take a strong stand to plug all loopholes in the manufacture and distribution of sub-standard quality drugs.

Recall Of Baxter Heparin And Its Implications
In the month of January 2008, the drug multinational Baxter Healthcare Corporation voluntarily recalled nine lots of heparin sodium injection multi-dose vials. This was on account of reports of four deaths and serious reactions supposed to have been caused by Baxter’s multiple-dose vials of heparin. It should however be noted that the suspension of manufacture Baxter Heparin relates only to Baxter’s multiple dose vials and not to other manufacturers of heparin or Baxter’s single dose vials.

Heparin
With the Recall Baxter Heparin having made headlines, it is pertinent that the public becomes aware of certain basic information on the drug. Heparin acts as an anti-coagulant, preventing the formation of clots. This drug is extensively used for the treatment of certain heart conditions such as myocardial infarction (heart attack), atrial fibrillation (abnormal heart rhythm), deep vein thrombosis (a condition known by formation of clots in deep veins) and during heart surgery. Heparin is also administered during kidney dialysis procedures.

Some Implications Of Baxter Heparin Recall
In addition to being a useful anti-coagulant, a great deal of potential has been foreseen for heparin as a developmental drug for the treatment of diseases like asthma, cancer, and arthritis. It remains to see what effect the present recall of Baxter Heparin will have.

Heparin Recall - Baxter Heparin - Baxter Manufactured Heparin

2008-06-30T12:49:00.000-07:00

Heparin recall issue has raised important questions. How could a Chinese company that had not been inspected be allowed to supply the active ingredients for heparin? Hundreds of patients have suffered serious allergic reactions to Baxter heparin and four deaths have been directly linked to this drug.

Heparin Recall - Legal Concerns
Heparin recall by Baxter International has raised many concerns. The drug was recalled after hundreds of patients suffered from serious allergic reactions. It has been reported that atleast 19 deaths could be attributed to counterfeit heparin. FDA reported that after these people were administered Baxter heparin, they experienced serious adverse allergic reactions- nausea, vomiting, difficulty breathing, excessive sweating and rapidly falling blood pressure.

Baxter Heparin
The problem was mainly found with Baxter manufactured Heparin. Upon investigation, it was found that samples of the active ingredient used in Baxter heparin included oversulfated chondroitin sulfate. Moreover, it was also found that chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. This ingredient was supplied by Changzhou SPL, a Chinese plant that had not been inspected by FDA.

After the findings, heparin recall was initiated by Baxter International. The company has stopped the production of multi-dose vials, which were the main cause of concern. In May, FDA found that there were serious gaps in recall response. Inspectors found stocks of recalled heparin on crash carts, in catheter labs and on hospital pharmacy shelves.

The problem is compounded by the fact that FDA is not fully cooperating with the Congress in getting to the bottom of the heparin recall issue. The regulatory authority is refusing to give the names of the Chinese companies who are responsible of supplying heparin ingredients. Moreover, the Chinese are reluctant to allow FDA to inspect the entire heparin supply chain.

The investigation into Heparin recall should also focus on whether Baxter intentionally allowed the use of the unapproved ingredient. Baxter simply cannot say that it did not know what the outsourcing companies were doing. The Food, Drug and Cosmetic Act prohibits anyone from introducing defective drugs into interstate commerce. In fact, FDA should take a very tough stance on this issue so that there are no such future instances.

Baxter Heparin - Baxter Heparin Products - Hep Lock Heparin Flush Products

2008-06-27T08:50:00.000-07:00

Because of repeated reports of adverse reactions of Baxter Heparin products, Baxter has finally announced a recall of its products from the market since January this year.

Recalling Of Baxter Heparin Products From Market

After so many reported adverse reactions of the Baxter Heparin product, the company finally decided to recall some of the major Heparin products, including HEP-LOCK Heparin flush products, single-dose vials, and Heparin sodium injection multi-dose. They started recalling the products from market in January this year. Both FDA and Baxter had the impression that recalling of these products earlier would have resulted in higher amount of risks for the patients who actually required Heparin therapy.

As a precautionary step, all Baxter Heparin products have been recalled from the market – despite the fact that the use of only multi-dose products were found to have adverse reactions. However, the recalling of these products does not include Heparin pre-mix IV solutions in bags, such as Heparin sodium in 0.9% sodium chloride injection and Heparin sodium in 5% dextrose injection.

There are basically three specific areas where the Baxter Heparin products have been found to have adverse reactions. These three specific areas include apheresis procedures, invasive cardiovascular procedures, and renal dialysis. Some of the major reported adverse reactions include bleeding tendencies, restlessness, decreased skin sensitivity, burning sensation, fast heart rate, shortness of breath, chest pain, diarrhea, and fainting and dizziness. Not all of these reactions are life threatening, but some of them are.

After Baxter Heparin products have been recalled, FDA has instructed people not to use the recalled products anymore. Those who have already purchased these products can get a return or replacement. You should note that use of these products cause rapid reactions. Therefore, if you had used one earlier and now after several months, you are experiencing some of the reported reactions, it may be because of some other reasons. Therefore, you must consult your health care professional before you proceed for a legal lawsuit.

Heparin and Adverse Side Effects Reports

2008-06-11T04:02:00.000-07:00

According to the FDA, there have been 131 reports of Heparin death reported since January 1, 2007; 123 of those heparin deaths were reported to the FDA on or after January 1, 2008.

For comparison purposes, the FDA reviewed the reports it received for all deaths of patients to whom heparin was listed as a potentially suspect drug in 2006. A total of 55 deaths were reported from January 1, 2006 to December 31, 2006 with an average of four or five per month.

Heparin deaths rose considerably due to the tainted heparin recall and the lack of Chinese and FDA production monitoring of heparin blood thinner.

FDA continues to receive reports of adverse events occurring after heparin administration. Patients, pharmacists, and medical professionals should report adverse events directly to the FDA via the MedWatch program and to consider hiring a lawyer, such as those at the Anapol Schwartz personal injury and wrongful death law firm, with offices in Pennsylvania and New Jersey.

The FDA receives approximately 400,000 reports of adverse events per year. The fact that someone reports an adverse event does not necessarily mean that a specific drug caused the medical event or death as reports will be analyzed to determine if there is a cause associated between the drug and the adverse side effect or death. Some patients have other medical conditions that can cause health-related problems.

Baxter Heparin Recall – Baxter Herparin - Heparin Recall

2008-06-07T12:42:00.000-07:00

Baxter heparin recall issue has shown how vulnerable patients are to contaminated drugs. Had the Chinese company been inspected by FDA, it is possible that the problem would not have occurred. Serious loopholes existing in our system need to be closed.

Baxter Heparin Recall - Thousands Of Lives Have Been Put At Risk
Baxter heparin recall is not just an isolated issue. Contaminated heparin has been found in ten other countries besides the USA. Authorities in Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, and New Zealand have also found oversulfated chondroitin sulfate, which is a contaminant, in heparin. Heparin is a blood thinner that is used by millions of patients every year. Heparin is used for anticoagulation in cardiopulmonary bypass for heart surgery, deep vein thrombosis, pulmonary embolism, and atrial fibrillation.

Who Is At Fault?
In USA, FDA has reported that there have been more than 1,000 cases where patients have reported one or more allergic reactions to heparin. More than 80 deaths have been associated with this drug. It was found that it was multi-dose heparin vials manufactured by Baxter International that were the main cause of concern. Upon investigation, it was found that the Baxter’s supply was contaminated by an animal like substance called oversulfated chondroitin sulfate. The ingredient was supplied by Changzhou SPL Company, which is based in China.

Since Baxter heparin recall, Baxter has been sued by a dozen of patients and their families in US. It has been found that due to some typo error, FDA had never inspected the Chinese supplier. Upon inspection, FDA found serious deviations from acceptable US health and safety standards. FDA has prohibited future US bound shipments from this plant.

Baxter heparin recall issue is something that the authorities should take very seriously. First, because it is a known fact that what can kill can cause serious damage to those who survive. When contaminated heparin is intravenously put into the body, it will circulate through every organ and cell. It is important to remember that patients have legal rights and there are laws that protect patients from contaminated drugs.

Baxter Heparin – Baxter – Heparin

2008-05-30T12:40:00.002-07:00

Baxter heparin multi-dose vials have been recalled after hundreds of patients suffered serious side effects, which included vomiting, sudden drop in blood pressure, nausea, and difficulty in breathing. At least four deaths have been linked to this drug.

Baxter Heparin - A Cause Of Serious Health Problems
Till recently, Baxter heparin made up roughly 50 percent of the heparin injections used in USA. In March, Food & Drug Administration (FDA) reported that it had found oversulfated chondroitin sulfate in the samples of heparin manufactured by Baxter. They also reported that since end of 2007, there had been 350 reported health problems that had been linked to heparin manufactured by Baxter. 40% of these problems were deemed serious.

Serious Side Effects
It has been found that after some patients were administered Baxter heparin injections, they experienced extreme allergic reactions. In some cases, the reactions proved fatal. Some of the allergic reactions that patients experienced include difficulty in breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure. At least four people have been reported to have died.

The FDA reported that the problems were mainly reported in patients who received high doses of Baxter Heparin over a short period of time. Also the problem was mainly found with the multi-dose vials. Upon investigation, FDA found that the Chinese plant that supplied the active ingredient in heparin had not been inspected by the agency.

Heparin is a blood thinner that is administered in surgery and other critical care situations to prevent clots. It is also known as heparin sodium. It is usually administered to patients undergoing dialysis and heart surgery. People who are bedridden are also administered heparin. The drug acts as a blood thinner and thereby helps in preventing the formation of clots. In a situation where a patient already has clots, heparin allows the body’s natural mechanisms to work normally so that the clots can be broken down. As of today, Baxter has stopped the production of Baxter heparin multi-dose vials pending further investigation.

Pa Lawyer - Pennsylvania Heparin Lawyer - Baxter Personal Injury Cases

2008-05-27T05:49:00.000-07:00

Who Is A PA Lawyer?

PA lawyers at Anapol Schwartz are Pennsylvania accident lawyers. If someone else’s carelessness has caused someone injury, then these lawyers would help the victim and his family get compensation for not only the medical bills, but also for the pain and suffering caused as well. You would come across many experienced and outstanding law firms which would surely take care of all your needs and help get you exceptional results.

Personal Injury Claims Can Include Injuries Like

• Automobile and motorcycle accidents
• Products liability or injury caused due to a defective product
• Sexual assault and molestation
• Slip, trip and fall
• Defective Products, such as Baxter Heparin that was manufactured in China and has been recalled.

The PA lawyer at Anapol can provide you with information on you legal options. They offer advice to clients on the necessary steps to be taken.

The PA lawyer who practices exclusively with personal injury cases is not intimidated by the tactics of the insurance company adjusters. You shoudl expect aggressive representation and personalized service when you hand over your case to a PA lawyer.

Baxter Heparin Recall - Baxter Heparin - Medical Negligence

2008-05-13T06:17:00.000-07:00

The Baxter Heparin Recall- Are You At Risk?

The Baxter Heparin Recall is the latest in defective drug scandals to hit the market. Heparin is a blood thinner, often used to prevent clotting after surgery or during dialysis. This usually harmless drug soon hit the headlines when it was discovered that there were deficiencies in the manufacturing of this drug, specifically in the company's plants located in China. The reactions to this drug have been diverse- while some have been lucky enough to just have an allergic reaction, as many as 21 people have died.

If you have just heard about the Baxter Heparin recall and have ingested the drug recently, check if you have the following symptoms. Have you had stomach cramps, nausea, vomiting, low blood pressure, excessive thirst and found it difficult to open your mouth? If so, you could be experiencing adverse reactions to this drug. Furthermore, you should start seeking legal action to gain some medical compensation.

If you or a loved one has been affected by the Baxter Heparin recall, you are in a legal position to sue because the drug that was prescribed was defective. Apart from that, you can also make a case for failure to warn and medical negligence. Another point to keep in mind involves the doctors and medical facilities. Though they have already been officially advised not to use Baxter Heparin, make doubly sure that they don't use it, in case you are undergoing a medical surgery.

Remember that some of the reactions to this defective drug have proven to be fatal so immediate action is required. If you or someone you know has been affected by the Baxter Heparin recall, contact a lawyer immediately.

FDA Fails to Regulate Heparin

2008-05-12T03:32:00.000-07:00

Within weeks, a man lost both his wife and son because of tainted heparin.

Both victims suffered from genetic kidney disease and both were being treated with heparin, a blood thinner used in the dialysis they needed to stay alive. These loved ones are among at least 81 people in the United States whose deaths from January 2007 to March 2008 have been linked to tainted heparin from China.

First there was tainted pet food then toys tainted with lead and now contaminated heparin once used to save lives instead of kill them. The FDA has failed to provide necessary protection, but this is every bit as much the responsibility of companies that contract with low-cost Chinese suppliers.

Baxter International, bought the heparin from a company in China but it contained a contaminant, oversulfated chondroitin sulfate, that mimics heparin yet costs 99% less.

During the congressional heparin hearings, it's become know that there was no proper inspections from either the Chinese version of the FDA or the U.S. FDA.

Baxter says that even with a rigorous inspection, it could not have detected the fake ingredient. Perhaps but it could have discovered, as the FDA did, that the Chinese plant, among other things, did not have control over its raw-materials suppliers.

Someone has to take responsibility and it's not the victim. If you or a loved one has been seriously ill or died from contaminated heparin, it is advisable to contact a lawyer to determine if you are eligible for a heparin lawsuit.

Source: USA TODAY

Suit Against Tyco Healthcare Alleges Tainted Heparin Caused Death

2008-04-29T06:09:00.000-07:00

Legal Intelligencer: A Philadelphia lawsuit against Tyco Healthcare was filed on behalf the estate of a Missouri man who died after allegedly suffering adverse reactions to heparin that was made in China.

The plaintiff's attorney alleged that the FDA is investigating 81 other deaths that have been linked to tainted heparin.

Baxter International Doubts Legal Problems over Heparin

2008-04-25T07:15:00.000-07:00

Baxter International does not expect issues with the recalled blood thinner heparin to cause major legal problems potential links to patient deaths.

Baxter announced a recall of heparin in February 2008 after numerous allergic reactions and deaths. Baxter said it’s hard to find concrete links between the drug troubles and deaths and doesn’t expect patient litigation. Baxter is thinking wishfully.

Baxter claims that only four deaths may be related to heparin when in fact there have been 62 deaths. So far dozens of lawsuits have been filed. If you or a loved one has experienced life threatening allergic reactions or death because of the heparin recall, please contact Anapol Schwartz law firm located in Pennsylvania and New Jersey so we may evaluate your options.

Despite the high-profile nature of the heparin troubles, the drug is not a major or high profit-margin product for Baxter. The stock declined by 1.1 percent.

Baxter hasn’t decided whether or not it will bring heparin back to the market, Heparin has a complex supply chain, with an active ingredient derived from pig intestines. Baxter needs to learn more about the cause of heparin problems and supply-chain controls before deciding how to proceed.

The FDA said that some heparin sourced from China was tainted with a certain product made from animal cartilage that is chemically similar to heparin's active ingredient but is considered cheap filler.

Baxter believes the contamination occurred at the crude level before it reached Scientific Protein Laboratories Chinese facility that processes the crude material into the active ingredient.

Red Flags Ignored for Heparin Contamination Problem

2008-04-23T08:22:00.000-07:00

The price of crude heparin exported from China rose from $629 per kilogram in January 2007 to $1,507 per kilogram in December 2007. The cost of refined heparin exported by China rose at about the same rate as that of raw heparin—strongly suggesting that the increase was driven by the price of the raw material rather than by processing problems.

The FDA was aware that the price of raw heparin increased dramatically but did not necessarily see it as a signal of potential quality problems. The rise apparently was the result of the blue ear disease. The FDA is looking at other possibilities.

The highly unusual increase of the price within a quarter of a year should have been a red flag to drug makers that something significant—and perhaps dangerous—was happening. Heparin contains a substance that is extracted from the intestines of pigs and is collected in slaughterhouses and on farms.

See: http://www.chicagotribune.com/business/chi-heparin_for_businessapr14,1,64884.story

Scientific Protein Laboratories said the price doubling did not raise any safety concerns but pharmaceutical industry experts say that a sudden increase in a stable price should have raised concern. Last month, the FDA discovered through chemical testing that heparin made in China had been contaminated with inexpensive over-sulfated chondroitin.

Was Baxter Heparin Intentionally Contaminated?

2008-04-21T11:22:00.000-07:00

During a senate hearing the FDA commented that they suspect that the blood thinner heparin was contaminated with cheap filler instead of heparin’s active ingredient to increase profit. The FDA failed to specify who added the contaminant. Baxter International said it happened before the product reached the company's supplier.

Later the FDA reneged on the statement saying there was no evidence that the heparin contamination was intentional.

Since January 2007, 62 people died after suffering allergic reactions or low blood pressure, from heparin. Heparin was recalled January 2008. Heparin prevents blood clots during dialysis and heart surgery.

The FDA hasn't concluded where in the supply chain the tainted material was introduced. See: http://www.boston.com/business/healthcare/articles/2008/04/16/fda_fears_heparin_tainted_on_purpose/

Heparin Sodium Recalls - Lawsuits

2008-04-11T11:09:00.000-07:00

Heparin Recall

If you have been injured by heparin sodium, you can contact our legal team with experience handling cases invovling dangerous medical devices and defective medications. The lawyers at www.anapolschwartz.com may help you to get the compensation that you deserve for the pain and suffering that you have endured as a result of your defective heparin sodium dose.

The U.S. Food and Drug Administration is investigating the New Jersey Baxter facility along with the Chinese facility that produced the heparin raw product to determine how the contaminate, oversulfated chondroitin sulfate, which does not occur naturally, got into the heparin batches. As much as half of the main ingredient in suspect Heparin supplies was found to actually be the contaminant. This chemical appears similar to the main ingredient in Heparin and produces the same results as Heparin during routine quality testing.. As a result of FDA investigations, China's drug safety agency has ordered local authorities to tighten controls on production. Baxter issued its own statement that also attributed the contamination to the Chinese suppliers.

FDA Pronouncements on Vitamins

2008-04-11T06:36:00.001-07:00

When it comes to FDA pronouncements most people assume these pronouncements are based exclusively on pharmaceutical drugs. This is why when the FDA announced potential recalls on vitamins many people found this surprising. But, it should not be surprising that the FDA opted to remove potentially harmful vitamins from the marketplace. After all, the role of the FDA is to protect consumers from harmful products that fall under the category of food or drugs and vitamins definitely fit into those categories. And even if they did not is it not a good thing that harmful products are being removed from store shelves.

Heparin Recall - Adverse Events

2008-04-08T12:14:00.000-07:00

About 700 adverse events associated with the Baxter product have been reported since the beginning of this year compared to less than 100 reports in 2007. Additionally, 19 deaths can be linked to the Heparin contamination.

Heparin is in a class of medications called anticoagulants or blood thinners. While heparin is very commonly used in the placement of IV catheters to keep those lines clear of blood clots, it is sometimes used in a bolus dose, a large dose given over a short period of time. Heparin bolus is routinely used prior to certain types of surgeries such as coronary artery bypass to prevent clots from forming during and after these delicate procedures. It is also used in kidney patients prior to undergoing dialysis. The reported adverse events occurred in patients receiving this large bolus form of administration.

The Origins of Heparin's Problems

2008-04-07T12:58:00.000-07:00

The blood thinner Heparin was once considered a miracle product then after several deaths it was obvious that this product needed to be recalled which it was. Heparin is yet another in a long line of products from mainland China that have been proven to possess serious adverse health risks. This is the problem inherent with dealing with a country that has significantly lower health and safety standards than the United States. Products being produced in China are not vetted and inspected to the same degree that products produced in the USA or Europe are. As such, companies such as Baxter take risks when working in conjunction with China based manufacturers as evidenced by the current recall disaster.

Product Testing and the Baxter/Heparin Recall

2008-04-04T10:58:00.000-07:00

What lessons are learned from the Baxter Heparin recalls? There are a number of lessons that derive from this and one of the most important is the fact that it is never wise to rush drugs to the marketplace without proper research and testing. When a product is released too soon problems such as the adverse reactions seen with Baxter Heparin are common. This is one of the reasons why the FDA requires such rigid testing of drugs. When drugs are released too soon and without a deeper understanding of the potential side effects of the drug many disastrous consequences can occur. This is why knocking the FDA's extensive testing and regulatory process is not always wise.

Covidien notified healthcare professionals of a voluntary recall

2008-04-02T13:34:00.000-07:00

Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.

Read the complete MedWatch 2008 safety summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#heparinsodium

The FDA Heparin Recall

2008-04-01T03:53:00.000-07:00

Although it is not a common occurrence it is not without precedence that the FDA will recall a drug from the marketplace. Such was the case with the very problematic drug heparin which turned out to be a drug that was far more problematic than most people would prefer to admit. While the company that produced the drug (Baxter) voluntarily recalled the product it happened in conjunction with the Food and Drug Administration's (FDA) public notification that this drug was known for causing numerous adverse reactions in those who took the drug. As such, it would go without saying that if the FDA lowers the proverbial boom on a drug the public should take such notice seriously.

The Baxter/Heparin Recall

2008-03-31T12:28:00.001-07:00

Probably one of the most frightening things someone with a serious medical condition can hear is that a product they are taking is part of a recall. After all, no company is going to recall a product that is without any serious problems. Obviously, the products that are recalled have been established to cause a number of complications and problems. Such was the case when the company Baxter recalled the blood thinner Heparin. This was a voluntary recall on the part of Baxter due to the severe number of adverse reactions in patients after they ingested the blood thinner. As such, if you are taking the product it would be best to call your physician immediately.

Blood Thinner Heparin Recalled World-wide

2008-03-28T13:29:00.001-07:00

The blood-thinning drug heparin has been recalled across the world, in three countries, France, Italy, and Denmark. The world wide heparin recall because it is believed that the heparin drugs are contaminated with the same contaminant which was found in U.S. supplies.
Heparin has been the focus of much attention in the U.S. and China over the past few months, but now is gaining attention around the world as well.

The European Medicines Agency believes the contaminant is in the supplies of heparin in all three countries.

The contaminant is known as chondroitin sulfate. Heparin made by Rotexmedica GmbH is being recalled in France, while the main ingredient is being recalled in Italy and Denmark. It is believed that the chemical was made by Italian company, Opocrin SpA.

Everything heparin related links back to China as the original source.

see: http://www.dbtechno.com/health/2008/03/26/blood-thinner-heparin-recalled-across-the-world/

Heparin Blood Thinner Recall Has a Domino Effect

2008-03-25T10:54:00.000-07:00

B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects the following 23 Finished Product (FP) lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.

B. Braun Medical Inc. began recalling the lots on March 21, 2008 as a precautionary measure. This product recall was initiated due to a notification received from the supplier, Scientific Protein Laboratories (SPL), disclosing that one lot of Heparin Sodium, USP Active Pharmaceutical Ingredient acquired by B. Braun Medical Inc. has a heparin-like contaminant. To date, B. Braun Medical Inc. has not received any adverse event reports related to this issue.

The Food and Drug Administration has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier Scientific Protein Laboratories, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

The affected heparin products are:
B. Braun FP Lot # - J7D490
B. Braun FP Material - P5872
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
NDC Numbers - 0264-9587-20

B. Braun FP Lot # - J7C684
B. Braun FP Material - P5771
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
NDC Numbers - 0264-9577-10

B. Braun FP Lot # - J7D496
B. Braun FP Material - P5771
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
NDC Numbers - 0264-9577-10

B. Braun FP Lot # - J7C470
B. Braun FP Material - P5872
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
NDC Numbers - 0264-9587-20

B. Braun FP Lot # - J7D580
B. Braun FP Material - P5671-00
Description - Heparin Sodium 20,000 Units in 5% Dextrose Injection (500mL)
CAN DIN - 02209713

B. Braun FP Lot # - J7E420
B. Braun FP Material - P5872-00
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
CAN DIN - 02209721

B. Braun FP Lot # - J7C611
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7C557
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7C477
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7C705
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7D485
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7E415
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7E416
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7E494
B. Braun FP Material - P5872
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
NDC Numbers - 0264-9587-20

B. Braun FP Lot # - J7E500
B. Braun FP Material - P5771
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
NDC Numbers - 0264-9577-10

B. Braun FP Lot # - J7E577
B. Braun FP Material - P5771-00
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
CAN DIN - 01935941

B. Braun FP Lot # - J7E489
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7N556
B. Braun FP Material - P5872
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
NDC Numbers - 0264-9587-20

B. Braun FP Lot # - J7P404
B. Braun FP Material - P5771
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
NDC Numbers - 0264-9577-10

B. Braun FP Lot # - J7N604
B. Braun FP Material - P5771
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (500mL)
NDC Numbers - 0264-9577-10

B. Braun FP Lot # - J7P476
B. Braun FP Material - P5872
Description - Heparin Sodium 25,000 Units in 5% Dextrose Injection (250mL)
NDC Numbers - 0264-9587-20

B. Braun FP Lot # - J7N519
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

B. Braun FP Lot # - J7N676
B. Braun FP Material - P8721
Description - Heparin Sodium 1000 Units in 0.9% Sodium Chloride Injection (500mL)
NDC Numbers - 0264-9872-10
CAN DIN - 01935933

Patients who experience adverse reactions, life threatening side effects, or quality problems from using the above products should report them to the FDA's MedWatch Adverse Event Reporting program by checking out www.fda.gov/medwatch/report.htm

Patients and/or their family members should consider contacting a law firm who has been zealous about medical malpractice, wrongful death, and product negligence lawsuits. Please contact Anapol Schwartz for your free, no-obligation consultation.

http://www.fda.gov/oc/po/firmrecalls/bbraun03_08.html

Heparin Contaminant Revealed

2008-03-25T10:41:00.000-07:00

Hypersulfated chondroitin sulfate, a common nutritional supplement, mimics the blood thinner in standard safety tests and may have been deliberately substituted to boost middlemen's profits.

The substituted supplement sickened hundreds of patients in the U.S. and is suspected in a number of deaths.The contaminant may have been added through a mishap or some kind of misguided experiment. Because of difficulties in checking, it's unclear whether the FDA will ever know for sure. The heparin contaminant announcement came on the anniversary of last year's massive recall of contaminated pet food when the FDA found a chemical added to pet food ingredients from China. The FDA clearly doesn’t have the resources to meet the demands to oversee all the drugs, medical devices, processed and natural foods. Inspections of foreign producers are infrequent and China has been difficult territory to regulate.

While Chinese facilities account for 22 percent of the foreign plants supplying drugs to the U.S. market, they received about 6 percent of the FDA inspections. To guard against future abuses, every drug manufacturer needs to inform FDA of where it sources its ingredients and what it is doing to ensure that these ingredients are pure and potent.

There have been other cases in which manufacturers and suppliers used unapproved materials to boost production capacity or to save money. This sounds like somebody in China figured out a way to make the active ingredient look or test like heparin when it was not.

See: http://www.latimes.com/news/printedition/asection/la-na-fda20mar20,1,4695849.story

Heparin Substituted with Cheaper Man-Made Chemical Contaminant

2008-03-24T09:42:00.001-07:00

The FDA has identified the contaminant found in the blood-thinner heparin, which has been linked to hundreds of allergic reactions and possibly 19 deaths.

The man-made chemical contaminant is oversulfated chondroitin sulfate which mimics heparin’s qualities and is a modified form chondroitin sulfate. The real chondroitin sulfate is a naturally occurring substance made from animal cartilage and used in supplements to treat arthritis. The man-made chemical is also less expensive than the real chondroitin sulfate.

The FDA did not know how this man-made chemical got into heparin.

The man-made contaminant was found in samples of heparin that the FDA tested from Scientific Protein's Changzhou SPL plant in China, which supplied Baxter with the active ingredient in heparin. It was also found in Baxter's heparin products in the United States.

Testing of these samples suggests that the contaminant accounted for approximately 2 to 50 percent of the total content of the active pharmaceutical ingredient.

Still to be determined is whether or not oversulfated chondroitin sulfate, when combined with heparin, can produce the serious allergic reactions and deaths.

Heparin is given to dialysis patients and people undergoing heart surgery. The raw materials for the drug come from the mucous lining of pig intestines. Many of those pigs come from rural farms in China, with the intestines often processed by unregulated mom-and-pop workshops before further processing at Scientific Protein's plant in Changzhou.

Since the end of December 2007, there have been 785 reports of allergic reactions associated with Baxter's heparin. In all of 2007, there were fewer than 100 adverse reaction reports.

see: http://www.iowahealth.org/body.cfm?id=168&action=detail&ref=23378

B. Braun's Supplier Recall of Heparin

2008-03-22T06:08:00.000-07:00

B. Braun's Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions. B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API).

All Heparin Imports Detained, FDA Says

2008-03-17T09:36:00.000-07:00

We know that there was a problem with Heparin. But it appears much worse than it first was reported. Now ALL heparin imports are being halted at the border for inspection and testing, by the Food & Drug Administration (FDA).

This decision follows reports of adverse reactions and deaths linked to Baxter Heparin. While Baxter began recalling Heparin, the FDA now has received about 350 reports of health problems associated Heparin. Nearly half of these reports were serious and four resulted in death.

What do the reactions look like? Thee reported problems include difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure.

Beyond Baxter, the FDA received over 750 reports of Heparin reactions. 19 of these were deaths in patients treated with Heparin. See: http://www.newsinferno.com/archives/2737

Heparin Lawsuits Are Being Considered By Anapol Schwartz.

Actor Says Medical Errors Kill 100,000 Patients a Year

2008-03-17T05:18:00.000-07:00

Actor Dennis Quaid speaks out about how hospital medical errors kill as many as 100,000 Americans a year. The Quaid twins nearly died last year when they were given a dose of heparin, an adult strength blood thinner, instead of Hep-Lock, a weaker version used to clearly IV lines for pediatric patients.

Quaid claims that more people are killed every year from medical errors than from AIDS, car accidents, and breast cancer.

The heparin injection created a life-and-death situation. Vials of Hep-Lock and Heparin look alike. The Quaids are suing Baxter International, the manufacturer of Heparin and Hep-Lock. A similar incident in Indiana resulted in the deaths of three infants which prompted Baxter to redesign packaging and issue a warning to hospitals.

Quaid feels Baxter should’ve recalled the product not simply issue a warning. Baxter feels that the product was safe and the onus is on the hospital to educate the staff about the sameness in the old packaging.

Three staff members at Cedars-Sinai Hospital in Los Angeles handled the adult dose of Heparin and failed to notice it was Heparin and not Hep-lock. Quaid is setting up a foundation that will look for remedies to human medical error. He feels his twins’ situation was completely avoidable.

See: http://www.cbsnews.com/stories/2008/03/13/60minutes/main3936412.shtml?source=mostpop_story

Sierra Pre-filled and B. Braun.

2008-03-10T08:14:00.000-07:00

Here are the FDA alerts for the nationwide recall of heparin and normal saline flushes manufactured by AM2 PAT, Inc. These pre-filled syringes are distributed under two brand names: Sierra Pre-filled and B. Braun. The syringes have been found to be contaminated with Serratia marcescens, which has caused patient infections that can be serious and even fatal. This recall applies to all sizes and strengths of these heparin and saline flushes. Health care professionals have been advised to quarantine them and return them to your distributor. For questions, contact the company at 919-552-9689.

(1) FDA Press Release. FDA Warns Public of Contaminated Syringes. January 25, 2008.
(2) FDA MedWatch Safety Alert. Heparin and Normal Saline Pre-Filled Flushes. January 18, 2008.
(3) FDA MedWatch Safety Alert. Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes). December 21, 2007.

FDA finds contaminant in suspect blood-thinner

2008-03-06T04:43:00.000-08:00

U.S. health officials said Wednesday they have found a contaminant in a blood-thinning drug produced by Baxter Healthcare Corp. that has been linked to more than a dozen deaths in the United States.

See: http://www.fda.gov/cder/drug/infopage/heparin/default.htm for the latest news from the FDA on Heparin.

FDA Warns Public of Nationwide Contaminated Syringe Recall for Two Brands

2008-03-04T11:44:00.000-08:00

January 25, 2008--The U.S. FDA today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun and sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL. Consumers should immediately let health care providers know that they have been exposed to syringes recalled by FDA.

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital.

The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections.
The growth of Serratia marcescens from unopened heparin syringes has been confirmed by the CDC.

Serratia marcescens, a bacterium found in water and soil, has been linked to pneumonia, blood infections, urinary tract infections, and wound infections. Some patients exposed to the recalled syringes have developed blood infections.

If you or a loved one has developed a blood infection or any infection from the recalled syringes, please do yourself a favor and contact Anapol Schwartz personal injury/product liability law firm. You may be eligible to file a claim and they can help and support you through the legal maze.

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, N.C.

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and SizesNormal Saline IV Flush Solution USP, All Strengths and Sizes

Sierra Pre-Filled Inc. Products:
64054-1003-02
1003-02
Heparin Lock Flush 100units/mL 5mL

64054-1003-01
1003-01
Heparin Lock Flush 100units/mL 3mL

64054-3005-02
3005-02
Heparin Lock Flush 10units/mL 5mL

64054-3003-02
3003-02
Heparin Lock Flush 10units/mL 3mL

64054-3003-06
3003-06
Heparin Lock Flush 10units/mL 3mL (6mL syringe)

64054-3005-06
3005-06
Heparin Lock Flush 10units/mL 5mL (6mL syringe)

64054-0910-2
0910-12
Normal Saline IV Flush 10mL

64054-0905-2
0905-12
Normal Saline IV Flush 5mL

64054-0903-2
0903-12
Normal Saline IV Flush 3mL

B. Braun Products:
64054-3005-02
513610
Heparin Lock Flush 10units/mL 5mL

64054-1003-01
513611
Heparin Lock Flush 100units/mL 3mL

64054-1003-02
513612
Heparin Lock Flush 100units/mL 5mL

64054-0903-2
513584
Normal Saline IV Flush 3mL

64054-0905-2
513586
Normal Saline IV Flush 5mL

64054-0910-2
513587
Normal Saline IV Flush 10mL

SEE: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01785.html

2008-03-04T11:42:00.000-08:00

Heparin Recall of Heparin Flush Syringes Expanded January 2008

AM2 PAT, Inc., of Angier, North Carolina, is initiating a nationwide recall of all lots of both Heparin and Saline pre-filled flushes manufactured by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes.

One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes was contaminated with Serratia marcescens, a resistant bacteria strain.

Consumers and healthcare facilities that have recalled pre-filled syringes, Heparin or Saline Lock Flush Solution USP, were advised to stop using the product immediately; products should be quarantined; and returned to the distributor immediately.

The following information for this recall includes:
MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina
PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, all strengths and Sizes
Saline Lock Flush Solution USP, all strengths and sizes

64054-1003-02
1003-02
Heparin Lock Flush 100units/ml 5ml

64054-1003-01
1003-01
Heparin Lock Flush 100units/ml 3ml

64054-3005-02
3005-02
Heparin Lock Flush 10units/ml 5ml

64054-3003-02
3003-02
Heparin Lock Flush 10units/ml 3ml

64054-3003-06
3003-06
Heparin Lock Flush 10units/mL 3ml (6ml syringe)

64054-3005-06
3005-06
Heparin Lock Flush 10units/mL 5ml (6ml syringe)

64054-0910-2
0910-12
Normal Saline Flush 10ml

64054-0905-2
0905-12
Normal Saline Flush 5ml

64054-0903-2
0903-12
Normal Saline Flush 3ml

The firm voluntarily recalled these products after confirming bacterial contamination in some end user samples of product code 1003-02, Lot 070926H which were distributed nationwide.
AM2 PAT, Inc.’s facility is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

See: http://www.fda.gov/medwatch/safety/2008/heparin_recall.htm

Heparin Recall of Heparin Flush Syringes Began December 2007

2008-03-04T11:41:00.001-08:00

On December 20, 2007 --- AM2 PAT, Inc., of Angier, North Carolina, began initiating a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes were found to be contaminated with Serratia marcescens.

Serratia marcescens is a kind of bacteria that is resistant to multiple antibiotics and presents a serious adverse reaction that could be life threatening or cause death.

The Centers for Disease Control have confirmed growth of Serratia marcescens from several unopened heparin IV flush syringes.

Consumers and user facilities who had these recalled pre-filled syringes, Heparin Lock Flush Solution USP, were advised to stop using the product immediately; quarantine the affected product; and return it to the distributor immediately.

The manufacturer is Sierra Pre-Filled, Inc., of Angier, North Carolina. The product description is Heparin Lock Flush Solution USP, 100 units/ml, 5ml, in pre-filled syringes.

LOT# NDC# CATALOG #070926H 64054-1003-02 1003-02

The firm voluntarily recalled the Heparin Lock Flush Solution after confirming bacterial contamination in some end user samples that was distributed nationwide to Florida, Texas, Illinois, Colorado, and Pennsylvania.

From an ongoing FDA inspection of AM2 PAT, Inc.’s facility, it appears the firm is not in compliance with the quality system regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

If you or a loved one has contacted an antibiotic resistant bacteria infection because of the heparin lock flush solution syringes – you should be consulting with a Pennsylvania law firm or a New Jersey law firm to find out what your legal options are. Medical products that save lives should make you healthier not sicker.

Source: http://www.fda.gov/oc/po/firmrecalls/am2pat12_07.html

More Die from Heparin Blood Thinner Recall

2008-03-04T11:14:00.000-08:00

The FDA said the possible number of deaths associated with Baxter International’s heparin recall rose to 21 people. Previously four people were said to have died which perpetuated the heparin recall among over 300 reports of adverse reactions. Since many of these patients were already seriously ill, there is no firm number as to the actual number of heparin recall deaths.

The FDA admitted to violating its own policy by failing to inspect the heparin prior to the factory shipping the heparin ingredient to Baxter in 2004. China’s drug agency also did not inspect the plant.

Consolidators were being investigated. One of the consolidators admitted to receiving heparin supplies from small unregulated family workshops that scraped mucous membranes from pig intestines, cooked it, to produce crude heparin. There were no inspections of any kind.

Among the potential problems facing FDA inspectors was crude heparin producers who failed to properly follow steps for identifying impurities and deficiencies related to manufacturing equipment.

The FDA’s concern about heparin revolved around Baxter’s multi-dose vials, but Baxter agreed to voluntarily recall not only the multi-dose vials but also single-dose vials and a diluted solution of heparin used to keep blood clots from forming in intravenous lines. The only heparin products made by Baxter that are still on the market are premixed bags of intravenous solutions.

The problems with heparin which prevents blood clotting during dialysis and after some heart surgery has now risen to 448 adverse reactions in a month. Adverse reactions include decreased or low blood pressure and fast heart rate.

The Chinese heparin market has been in turmoil over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market. The investigation continues.If you or a family member is a victim of the heparin recall, please contact the Anapol Schwartz personal injury/wrongful death law firm with offices in Pennsylvania and New Jersey. You may be eligible for a settlement. Find out what your legal options are.

see: http://www.nytimes.com/2008/02/29/us/29heparin.html?em

Chinese Heparin Maze Where Regulations Cease to Exist

2008-03-04T11:10:00.000-08:00

FDA investigators are trying to trace where the raw material for the blood thinner heparin leads. Heparin which is made from pig intestines is contaminated and an unyielding maze of slaughterhouses awaits the unknown American investigator.

The president of the American company Scientific Protein Laboratories that owns a majority of the unregulated Chinese company claims that the collection chain for pig intestine suppliers is in place inspectors in China and the United States are not so sure.

A pig disease swept over China depleting its stock of pigs. Some farmers sold their sick pigs for heparin production nevertheless. With no regulations and no rules including sanitation there is no foresight into the small village operations.

The number of reports of heparin adverse reactions continues to rise and has surpassed 400. So far the authorities have not discovered the problem with the heparin supply chain and no firm findings have been announced.

The heparin recall has directed focus on the quality of products from China and the gaps in regulation by both the Chinese and United States governments. Scientific Protein Laboratories’ plant in Changzhou was certified by American officials to export to the United States even though neither the Chinese government nor the American government ever inspected it since 2004.

This company is not alone as many companies have fallen between the cracks because it is known as a producer of chemical ingredients not a drug manufacturer.

The process of making heparin starts with the intestines of slaughtered pigs, from which the mucous membrane is collected and cooked, eventually producing a dry substance known as crude heparin.

Major heparin producers like Scientific Protein Laboratories take that substance, refine it, and sell it to big pharmaceutical companies who make the final product, which is widely used in dialysis and CABG.

Most of China’s crude heparin comes from small factories in poor villages where houses double as heparin mining. Working conditions are taxing, dilapidated, and a crap shoot.

Source: http://www.nytimes.com/2008/02/28/world/asia/28drug.html?ref=us

FDA Alert: Total Baxter Heparin Recall

2008-03-04T11:07:00.000-08:00

February 28, 2008 – Baxter International Inc. announced that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials, and HEP-LOCK heparin flush products.

Baxter International initially recalled only nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to high number of adverse patient reactions involving the product and suspended production earlier this month.

At that time the FDA and Baxter did not advise a total recall because of the widespread use of this blood thinner and the impact a product shortage would have on operating rooms and dialysis centers.

However, now the FDA has concluded that there is sufficient amount of heparin on the market mainly in part based on other suppliers that the Baxter's heparin recall will create a shortage. FDA told Baxter International to recall its remaining heparin sodium injection and heparin flush products.

Although the vast majority of the reports of adverse reactions have been associated with the multi-dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market.

This heparin recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.
Baxter is working with the FDA to determine the cause of the high number of adverse reactions to resolve the issue. Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures, and apheresis procedures.

Adverse reactions have included stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some reactions like an extreme drop in blood pressure may be life-threatening.

If you or a loved one has suffered serious adverse reactions due to heparin, please contact the law firm, Anapol Schwartz, with offices in New Jersey and Pennsylvania. You may be entitled to a product liability settlement.

Source: http://www.fda.gov/oc/po/firmrecalls/baxter02_08.html

Heparin Recall, Kidney Dialysis, and Innocent Victims

2008-03-04T10:59:00.000-08:00

Imagine that you are a kidney dialysis patient and spend the better part of a week going to a kidney dialysis center where this lifesaving treatment keeps you alive until you can have a kidney transplant.

While you lay quietly reading, watching TV, or talking, you are hooked up to a machine that filters harmful waste and excess salt and fluids from your blood. For people who don’t have kidney disease, their kidneys do for them what the dialysis does for people with kidney failure. Hemodialysis severely limits your time and ability to lead a normal life.

Part of the dialysis procedure requires that you also receive injected blood thinner known as heparin to prevent blood clots from forming in the dialysis machine and tubing.
Kidney dialysis patients lead fragile lives.

All facets of treatment must be delivered with precision. There is no room for human error or computer error.

Unfortunately, bad things happen when mega million dollar making pharmaceutical companies put profit before people; when the necessary blood thinner known as multi-dose vial heparin causes over 300 adverse reactions in a few short months. Worse, at least four vulnerable people have died from this lifesaving treatment and most likely that number will grow as the heparin problems become more known. Children with kidney disease have also been victims of the heparin recall.

Adverse reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock.

Since late December 2007, the Food and Drug Administration and Baxter Healthcare have received around 350 adverse event reports with approximately 40 percent deemed serious. Most of the cases happened at kidney dialysis centers although some cases include vulnerable patients undergoing heart surgery. Hospitals and healthcare professionals rely on blood thinners like heparin to keep patients safe.

Baxter Healthcare and Baxter International have had a litany of recalls in previous years. According to the FDA web site http://www.fda.gov/cdrh/recalls/recall-121305.html, Baxter’s infusion pumps were recalled three times in 2005. Electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream. The pumps can shut down while supplying critical medication and fluids to patients. Critically ill patients needing continuous delivery of life-sustaining medications at the time of the pump’s failure could be seriously harmed.

The product failures leave a major onus on the hospitals. Baxter and the FDA recommend that these healthcare institutions have a backup pump available to mitigate any disruptions of infusions of life-sustaining drugs or fluids.

Once again Baxter has placed dialysis centers and other healthcare institutions in a precarious position by providing them with injurious batches of heparin. What is so unbelievable is that the prime active ingredient of heparin (pig intestines) under suspect has never been inspected by the Chinese version of the food and drug administration nor by the U.S. Food and Drug Administration.

Is quality management not a concern at Baxter International?
Fortunately, other multi-dose vials of heparin on the market have been zealously inspected by both the Chinese drug agency and the FDA. APP Pharmaceuticals, Inc. has heparin that has been inspected.

But back to the unsuspecting kidney dialysis patient who has a fragile grasp on life.
What are their options? How do they and their family cope with a harmful dose of uninspected heparin?

If this is you or you know of someone who is a victim of the heparin recall, please ask them to contact Anapol Schwartz, a personal injury, wrongful death, product liability law firm with locations in Pennsylvania and New Jersey.

Baxter Healthcare International must pay the victims or their family members for disregarding public product safety.

Another Firm in China Regulated for Heparin

2008-03-04T10:57:00.000-08:00

Baxter International Chinese supplier, Changzhou SPL which is a joint venture with a Wisconsin company was never inspected by the Food and Drug Administration, nor was it registered with Chinese drug regulators.

Baxter’s Heparin rival, Shenzhen Hepalink Pharmaceutical Co., spent almost five years getting ready for U.S. regulatory approval. Heparin, a widely used blood thinner, was once made from cow lungs but drug makers shifted to pig intestines as concerns over mad cow disease increased in the 1990s. Baxter said that tests detected irregularities in samples of the drug processed with ingredients from China.

Since 2005, Hepalink has been inspected nine times by Chinese and foreign authorities and audited 25 times by Hepalink's customers, including five times by its U.S. client, APP Pharmaceuticals Inc.

Less than three dozen companies are listed with China's drug regulatory agency as qualified makers of heparin ingredients. The reason for the discrepancy isn't clear, but some companies are registered not as drug producers but as chemical makers such as is the case of Baxter International’s company. Hepalink's workshop and labs are filled with equipment imported from the U.S., Europe and Japan and if there is a problem there is the ability to trace it to individual groups of pigs to ensure quality and safety of the final product.

What Is Heparin's Chemical Composition

2008-03-04T10:54:00.000-08:00

Heparin Ingredients

Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties to prevent the blood from clotting. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6- sulfate, (3)β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-a-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.

Structural formula of Heparin Sodium (representative sub-units):
Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine (swine) insulin obtained from pig pancreas. A porcine skin graft is one in which pig skin is used administered by intravenous or deep subcutaneous routes.

Source: http://www.rxlist.com/cgi/generic/heparin.htm

All about Heparin

2008-03-04T10:53:00.001-08:00

Heparin is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing medical procedures that increase the chance that clots will form. Heparin is also used to stop the growth of clots that have already formed in the blood vessels, but it cannot be used to decrease the size of clots that have already formed. Heparin is in a class of medications called anticoagulants or blood thinners.

Heparin comes as a liquid solution injected intravenously into a vein or deeply under the skin and as a less concentrated solution to be injected into intravenous catheters. Heparin should not be injected into a muscle. Heparin is sometimes injected 1-6 times a day and sometimes given as a slow, continuous injection into the vein.

Heparin may be given by a nurse or other healthcare provider or you can inject the medication by yourself. When injecting heparin yourself, a healthcare provider will show you how. Heparin solution comes in different strengths. Using the wrong strength may cause serious problems. Before giving an injection of heparin, check the package label to make sure it is the strength of heparin solution that your doctor prescribed.

Heparin is also sometimes used alone or in combination with aspirin to prevent pregnancy loss and other problems in pregnant women who have experienced these problems in their earlier pregnancies.

Before using heparin, tell your doctor and pharmacist if you are allergic to heparin, any other medications, beef products, pork products, or any of the ingredients in heparin injection. Ask your doctor or pharmacist for a list of the ingredients.

Tell your doctor if you have a low level of platelets in your blood and if you have heavy bleeding that cannot be stopped anywhere in your body. You may not be a candidate for heparin.

Tell your doctor if you are currently experiencing your menstrual period; if you have a fever or an infection; and if you have recently had a spinal tap; or a heart attack. Also tell your doctor if you have or have ever had a bleeding disorder such as hemophilia, blood clots in the legs, lungs, or anywhere in the body, unusual bruising or purple spots under the skin, cancer, ulcers in the stomach or intestine, a tube that drains the stomach or intestine, high blood pressure, or liver disease.

Heparin may cause serious side effects; call your doctor immediately for unusual bruising or bleeding, bloody vomit or vomit that looks like coffee grounds, black/tarry stool or bloody stool, blood in urine, excessive tiredness, nausea, chest pain, discomfort in arms and neck, coughing up blood, excessive sweating, severe headaches, hives, fever, chills, itching/burning at bottom of feet, difficulty speaking, loss of balance/coordination, difficulty seeing, numbness on one side of the body, difficulty breathing, painful and long lasting erection, hoarseness, wheezing, and rash.

Source: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682826.html

Alternatives to Heparin

2008-03-04T10:51:00.000-08:00

According to the Journal of American Medical Association, two major studies suggest that anticoagulant therapy with enoxaparin is an effective alternative to heparin therapy for patients with acute coronary syndromes (ACS.

In the first study, investigators compared the outcomes of patients treated with enoxaparin vs. unfractionated heparin. Although previous trials have demonstrated the superiority of enoxaparin compared with unfractionated heparin for patients with non-ST-elevation (a certain pattern on the electrocardiogram) ACS receiving medical therapy as their primary treatment strategy, the value of enoxaparin as the principal anticoagulant regimen for ACS has been debated.

The trial was a randomized international trial conducted between August 2001 and December 2003. A total of 10,027 high-risk patients with non-ST-elevation ACS to be treated with an intended early invasive strategy were recruited. Participants received either subcutaneous enoxaparin or intravenous unfractionated heparin administered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician.

The primary efficacy outcome was the composite clinical end point of death or nonfatal myocardial infarction during the first 30 days after randomization. The primary safety outcome was major bleeding or stroke.

The researchers found that the primary end point of death or nonfatal MI by 30 days occurred in 14.0 percent of patients assigned to enoxaparin and 14.5 percent of patients assigned to unfractionated heparin. Enoxaparin was not superior to unfractionated heparin but fulfilled the non-inferiority criteria.

In a related study, investigators with the A to Z trial assessed whether combining enoxaparin with the glycoprotein IIb/IIIa inhibitor tirofiban and aspirin is a suitable alternative to the current standard combination of unfractionated heparin with tirofiban and aspirin, in patients with non-ST-elevation ACS.

Analysis of the 3,987 patients randomized into phase A of the A to Z trial revealed a 1 percent absolute and 12 percent relative difference in favor of enoxaparin compared with unfractionated heparin for the prevention of the composite end point of death, MI, or refractory ischemia. This benefit did not meet criteria to declare superiority but fell well within specified bounds for non-inferiority. These trends should be interpreted with caution in the absence of a finding of superiority; however, they are consistent with prior studies of glycoprotein IIb/IIIa inhibition with tirofiban and previous studies comparing enoxaparin with unfractionated heparin, which found greater relative efficacy among higher risk patients.

"Because it is easier to use and modestly reduces recurrent ischemic events without an increase in the need for blood products, enoxaparin compares favorably with unfractionated heparin in patients with non-ST-segment elevation ACS who are receiving tirofiban and aspirin.
Both the A to Z and SYNERGY trials provide evidence that enoxaparin remains a reasonable alternative to unfractionated heparin in contemporary ACS treatment. Enoxaparin has several unique benefits and apparently few limitations.