A final report on the deadly contamination of the blood thinner heparin confirms that the problem was caused by a man-made chemical that was added to batches of the drug imported from China, The Washington Post recently reported.
The crisis, which began in November 2007, resulted in 152 adverse reactions and as many as 81 deaths in the United States. The Chinese heparin, contaminated with the chemical oversulfated chondroitin sulfate (OSCS), was found in at least 10 countries, according to federal officials.
Published in the December 18, 2008 issue of the New England Journal of Medicine, the report “describes the adverse reactions caused by the contaminant” and links it to a specific substance, Dr. Priti R. Patel, a medical epidemiologist with the U.S. Centers for Disease Control and Prevention, explained. The reactions included a drastic drop in blood pressure, nausea and shortness of breath, starting within 30 minutes after the administration of the heparin.
“There is a definite link between this contaminant and the patients who had these reactions,” Dr. Patel said.
The first reports of such reactions among hospital patients given heparin came in November 2007. Eventually, cases were reported in 13 states. Investigators found a common thread in those cases: heparin marketed by Baxter Healthcare, of Deerfield, Ill., which got its supplies from China. A full list of drugs and medical devices potentially affected by the contaminated heparin can be found on the FDA web site.
Raw heparin is derived from pig intestines. It is given intravenously to prevent blood clots during certain kinds of surgery, and also is used by people with kidney disease requiring dialysis. In China, heparin often is made by small, unregulated companies.
Most of the reactions reported in the United States occurred in dialysis centers among people given high initial doses of heparin, the report found.
From a legal standpoint, a manufacturer of a defective drug can be liabile for any damages or injuries suffered by a user as a result of that defective drug.
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