By the end of February, 2008, the FDA reported 21 deaths and approximately 350 allergic reactions linked to heparin. The
heparin allergic reactions included difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that could lead to life-threatening shock and death.
The FDA announced on March 21, 2008 that B. Braun Medical Inc., a supplier of Heparin in Canada, began recalling heparin solutions as a precautionary measure. At the same time, Health Canada announced that the company's heparin products were tainted. Braun has recalled 23 lots (of 25,000 units each) that were distributed to Canada, Australia and the United States.
The FDA has now discovered that the raw ingredient in the contaminated heparin came from China. It was actually doctored with chondroitin sulfate, a widely used, over-the-counter dietary supplement made from animal cartilage and used to treat joint pain. When chondroitin sulfate is altered, or "oversulfated," it mimics the blood-thinning action of heparin.
Although it isn't clear whether oversulfated chondroitin sulfate was added deliberately or accidentally, the agency does know that the doctored drug did not occur naturally or as a result of the manufacturing process. Furthermore, there are some reports that the cost of heparin had risen dramatically, thanks to an outbreak of swine flu in China. Oversulfated chondroitin sulfate is reportedly cheaper to produce than heparin.
Heparin is used in patients undergoing kidney dialysis, certain types of cardiac surgery and treatment of other medical conditions, including pulmonary emboli. It is used to decrease the clotting ability of a patient's blood and is made from pig intestines.
Scientific Protein Laboratories (SPL) of Waunakee, WS has been supplying heparin to the US for 30 years and it supplied Baxter heparin in its raw form. SPL moved the plant to China three years ago because the country was the biggest pig producer in the world.
The FDA approved the plant in Changzhou to provide heparin to the US in 2004 but the agency never actually inspected it prior to approving it. Now, the FDA is now under fire for approving Baxter's heparin without inspecting the plant. The agency has admitted that it violated its own policies by neglecting to inspect SPL's Chinese plant before approving the drug for sale in the US.
Washington, DC: An allegation of conflict of interest that grew out of the heparin contamination case of 2008 is still very much alive today. While patients became ill and died from tainted heparin injections, the director of the FDA's Center for Drug Evaluation and Research found herself embroiled in controversy. [ 
Lufkin, TX: The family of a man who allegedly died from complications arising from a contaminated heparin injection has filed a product liability lawsuit against the makers of the blood thinning agent, Baxter, and the medical facility that administered the drug. [ 
Seattle, WA: Andie was admitted to the hospital for three days with a back injury and was given several shots of heparin. A nurse told her that heparin injections were mandatory, even though Andie said she didn't want them. [ 
