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Baxter blood thinner has been put on ice while the Feds examine the huge increase in adverse reactions.
Baxter Healthcare has temporarily suspended manufacture of multidose vials of the anticoagulant Heparin, after reports of severe allergic reactions and hypotension—including four deaths—after administration of large doses of the drug.
According to FDA, the number of adverse events involving the drug spiked from 100 in 2007 to nearly 350 since the beginning of 2008. Approximately 40 percent of the incidents are listed as serious.
Nine lots of the drug were voluntarily recalled in January; however, FDA has since tracked adverse reactions well beyond the recalled lots.
Side effects from the drug have ranged from difficulty breathing, nausea, vomiting, and excessive sweating to rapidly falling blood pressure.
FDA stated that the drug is often administered prior to coronary artery bypass graft surgery, and to kidney patients before they undergo dialysis. In some situations, Heparin treatment is initiated using a high-bolus dose intravenously over a short period of time, usually less than one hour. The reported adverse events occurred in patients who were given Heparin via this method.
"FDA concurs with Baxter's decision to halt manufacture of heparin sodium in multiple-dose vials," said Janet Woodcock, FDA deputy commissioner for scientific and medical programs. "FDA is vigorously investigating to determine the root cause of these serious reactions associated with the use of heparin made by Baxter. In the meantime, patients and healthcare professionals who cannot obtain alternative sources of heparin should use caution in administering any Baxter multiple-dose vials that remain."
The Wall Street Journal on Thursday reported that a Chinese plant that supplies Baxter with the active ingredient for the drug is under investigation. By Monday, Bloomberg was reporting that the failure to inspect was caused by a mix-up with another plant with a similar name.
Baxter controls about 50 percent of the US heparin market, for about $30 million in revenue. Its principal competitor in the heparin business is APP Pharmaceuticals of Schaumburg, IL, which announced yesterday that it was working closely with FDA to ramp up production of its heparin product to help stave off a shortage.