Heparin is an anticoagulant used to prevent the formation of blood clots administered for a number of conditions, including acute coronary syndrome, arial fibrillation, deep vein thrombosis, peripheral arterial embolism, and pulmonary embolism. A major manufacturer of heparin in the U.S. and elsewhere is Baxter International, Although heparin is effective at preventing the formation of new blood clots, the drug has been associated with some serious side effects, such as excessive bleeding, osteoporosis, hyperkalemia (high potassium level), and heparin-induced thrombocytopenia (HIT), a condition in which the immune system destroys red blood platelets.
The FDA has issued two recall of heparin in the past few years. Heparin was recalled in December 2007 after the FDA learned of a possible contamination by the bacteria Serratia marcescens, which can be fatal. Then in March 2008, another recall was issued for all heparin manufactured in China because it was found to be over-sulfated, which is believed to be responsible for causing severe allergic reactions in nearly 800 people.
Baxter International is accused of substituting the active ingredient in heparin with over-sulfated chondroitin sulfate, which mimics the active ingredient and is much less expensive to produce. According to the lawsuits, the contaminated heparin should have been identified during Baxter's quality tests, which could have prevented individuals from suffering allergic reactions with potentially fatal complications.