Health Canada: important information on changes to heparin potency

Health Canada is informing health care professionals and Canadians of recent changes to heparin manufacturing standards in the United States that will result in a decrease in the potency of certain heparin products by about 10 per cent

U.S. Health officials announce new heparin formula

"U.S. health officials on Thursday announced new manufacturing standards for the widely used blood-thinner heparin that will decrease the drug's potency by about 10 percent. The reformulation is largely a response to contaminated heparin that came from China in 2007-2008 and caused hundreds of severe reactions and 200 deaths among U.S. patients, most of whom were on kidney dialysis. While the new standards take effect October 1, the four U.S. manufacturers of heparin have already started making units under the new guidelines, which will make it easier to spot impurities." - HealthDay

Tainted drug caused allergic outbreak (USA)

"The cause of an outbreak of severe adverse reactions that occurred at hemodialysis facilities across the country early this year has been identified. Vials of heparin manufactured by Baxter Healthcare and contaminated with oversulfated chondroitin sulfate have been shown to be responsible for a widespread outbreak of adverse reactions to hemodialysis treatment that affected 152 people and covered 13 states. Reactions to the contaminated heparin included facial edema, or swelling, low blood pressure, nausea and shortness of breath. Researchers at the Centers for Disease Control and Prevention found of 130 adverse reactions, 128 occurred in a facility that contained OSCS-contaminated heparin. They also found out of 54 reactions, 52 occurred after the administration of contaminated heparin. heparin is a medication derived from pigs that is used to keep blood from clotting. It is often administered to treat blood-clotting disorders and to prevent clotting during procedures like hemodialysis and cardiac surgery. Source: New England Journal of Medicine, 2008;359:2674-2684 - HealthScout