Heparin: Contaminated Batches Pulled Around World

Stockholm, SwedenContaminated batches of the drug Heparin have been pulled from the shelves in the United States and now have been pulled from the market in Sweden. This move comes after researchers identified the contaminant as oversulfated chondroitin sulfate. Luckily, health regulators now have a test in place that is designed to detect Heparin that is contaminated. But how did the contaminated Heparin slip through the cracks in the first place?

Researchers revealed on April 24, 2008 that Heparin, whose main ingredient is imported from China, is only tested for lipids, protein, and DNA. The tests were not designed to test for oversulfated chondroitin sulfate or any other substances. The oversulfated chondroitin sulfate is a derivative of animal cartilage. And it just so turns out that the substance is structurally similar to the ingredients used in Heparin since Heparin's main ingredient is made from pig intestines.

As for Sweden, health officials only pulled four batches of Heparin as a precautionary measure. They do not know much about the contaminant, but they have not had any injuries or deaths reported in those patients who were administered the drug.

Even U.K. Health officials have advised doctors to keep their eyes open for any side effects after administering Heparin. However, the U.K. officials have not gone as far as to pull the drug from the market because they feel the small amount of contamination is not enough to take such action. This is because the U.K. uses a different Heparin supplier than some healthcare facilities in the United States. The United States has received Heparin from the drug maker Baxter, and it is the Baxter Heparin that has been linked to 81 deaths. Europe receives their Heparin from Lovenox, which doesn't import ingredients from China. Any contamination that has appeared in the Lovenox version is approximately one tenth of that found in the Baxter version, which accounts for 50% of the Heparin used in the United States. Baxter imports its ingredients from China, which is where the oversulfated chondroitin sulfate has been traced back to.

Right now, the FDA is investigating the China-based supply chain that Baxter receives its main ingredient from. The FDA is leaning toward the possibility that the supply may have been intentionally contaminated with the substance that looks similar to Heparin. The belief is not that it was to hurt people, but to increase their profits as a supplier.

As it stands, Baxter is not sure that they are going to re-release Heparin onto the market. Chairman and CEO Robert Parkinson has entertained the idea of not selling the vials of Heparin in the U.S. The decision is still up in the air because the company is currently working to understand and correct what got them to this point. This starts with making sure there is nothing inappropriate occurring within the supply chain. Still, the FDA has not determined exactly what happened that led to the oversulfated chondroitin sulfate contamination. Everything so far is just theories.

Nevertheless, the contaminated Heparin has been found in 11 countries around the world. Those who have lost loved ones are seeking answers and Baxter is facing a number of lawsuits over the contaminated drug. One such suit was filed in early April after a New Jersey man claimed he almost died from a severe adverse reaction after receiving an injection of Heparin.

At this point, everyone is awaiting investigation results from the FDA.

By: Ginger Gillenwater