Heparin and the China Connection

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

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

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

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

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.