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NEJM Identifies Heparin Recall Contaminant to be Oversulfated Chondrotin (OSCS)
December 8, 2008
In November 2007, health officials, including the Food and Drug Administration (FDA), began receiving a spike in adverse event reports describing allergic-type reactions associated with the use of heparin, an anticoagulant (blood thinner). Heparin is commonly used in surgical procedures and dialysis treatment to prevent blood clots.
In January 2008, Baxter Healthcare issued a heparin recall for nine lots of their multi-dose vials. The company subsequently expanded the recall in February 2008 to include all forms of heparin it had sold, which was about half of the injectable heparin sold in the United States.
The FDA has been testing the recalled heparin and found the presence of a fake chemical, oversulfated chondroitin sulfate (OSCS), which was added to the raw heparin ingredients at a plant in China, which is owned by Scientific Protein Laboratories. On December 3, 2008, the New England Journal of Medicine published an article reporting on the source of the contamination.
The precise source of where the fake chemical entered the manufacturing process has not been identified but FDA sources have suggested that it was likely used for fraudulent and economic reasons. The fake ingredient is chemically similar to the appropriate ingredient in heparin, yet it is substantially cheaper.
So far, there have been at least 152 confirmed heparin reactions in the United States. 81 death have been associated with the use of the tainted heparin. Researchers expect that this number, however, represents no more than ten percent of the actual number of adverse reactions from the heparin contamination because most adverse events are not reported or not identified by doctors or the patient as being associated with the use of heparin.
The potential adverse reactions related to the contaminated heparin include sudden development of allergic-type reactions, such as:
- Shortness of breath
- Nausea
- Vomiting
- Severe drop in blood pressure
According to Chemical and Engineering News, the new study reported in the NEJM compared 21 dialysis facilities that reported reactions and 23 control facilities that reported no reactions. The NEJM study found that Baxter manufactured heparin was in all of the facilities that reported adverse reactions but was in only 4.3% of the control facilities.
The researchers further investigated the 152 heparin reactions reported in 113 patients. Not all of the reactions could be correlated with specific lots of heparin but of 54 cases in which clinicians had recorded the specific lot of heparin given to patients, 52 patients had received the contaminated heparin.
Chinese officials disputed the link between the heparing deaths and oversulfated chondroitin sulfate when the link was reported early on during the recall. The report released by the NEJM on December 3, 2008, however, confirms the link. “This epidemiologic study provides additional confirmation that oversulfated chondroitin sulfate caused the adverse reactions seen in patients,� said Janet Woodcock, director of the FDA’s Center for Drug Evaluation & Research.
So far, over 50 lawsuits have been filed in the Untied States over the recalled heparin. The cases filed in federal court are consolidated in the U.S. District Court for the Northern District of Ohio in a multi-district litigation (MDL) proceeding titled: Heparin Multi-District Litigation MDL No. 1953. The case is assigned to the Honorable Chief Judge James G. Carr. Several hundred lawsuits are expected to be filed in the coming months.
If you or a loved one had an allergic reaction to Heparin, contact one of our Heparin recall lawyers today.
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