Heparin Deaths vs. Rat Vomit, Which is Worse?

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?

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 Another oral alternative is Ximelagatran which seemed to be very effective but has since been withdrawn due to issues with toxicity.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

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

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

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

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.