Imports of heparin, a blood thinner used in surgery and kidney dialysis to prevent clotting, have been stopped at the border by the FDA to test for a contaminant. The contaminant was found in the drug thinner’s raw ingredient, pig intestines, and is linked to hundreds of allergic reactions and 19 deaths.
The contaminant was found in 20 of 28 samples of raw heparin tested by the FDA. The raw ingredient is supplied by a Chinese factory, which is owned by Scientific Protein Laboratories in Wisconsin. Illinois-based Baxter International Inc. then supplies heparin to hospitals around the country. They are one of the main suppliers of heparin in the U.S.
This latest news stems from an earlier suspension and recall of heparin announced in February by the FDA. At the time that story broke, almost 450 allergic reactions and 21 deaths had been linked to contaminated heparin. The deaths have apparently been revised down to 19. No additional deaths and only two allergic reactions have been reported since last month’s recall. Allergic side effects include increased heart rate and lower blood pressure.
Prime Suspect
When the FDA and Baxter announced the recall, the link between the contaminant and the allergic reactions and deaths was “tenuous.” And because scientists have yet to identify what the contaminant is, there is still some uncertainty as to whether it caused the reactions and deaths. The uncertainty is due to the contaminant closely mimicking heparin’s structure so it is not caught by standard drug-purity tests. FDA drug chief, Dr. Janet Woodcock, believes they are close to identifying the substance, as well as determining if it got into the heparin accidentally or through fraud.
The pig intestines used in heparin come from small family-run workshops in China. These are located near slaughterhouses, where the ingredients are then given to middlemen before they reach larger factories. The FDA hasn’t inspected these workshops, so it isn’t clear exactly where the contaminant might be. It has been surmised that due to pig diseases that depleted the stock of healthy animals used, the Chinese were buying sick pigs in the market. This forced Chinese producers to look for alternative sources, which often are located in villages with unsanitary conditions.
While worldwide testing has begun to make sure heparin is contaminant-free, five of the nation’s leading heparin manufacturers will perform the testing on imports. The FDA will not name these five companies and do not plan on spot checking the quality of the tests.
If you, or a family member, believe you have suffered an allergic reaction due to contaminated heparin, please contact a personal injury lawyer with experience in pharmaceutical liability.
