Baxter Suspends Multidose Heparin Production After Allergic Reactions

-FDA News

02/13/2008 - Baxter and the FDA are investigating manufacturing facilities and processes for multidose Heparin after a spike in serious adverse events associated with it caused the company to suspend production of multidose vials of the drug.

Four people have died after receiving heparin, although the relationship to the drug is unclear, the FDA said in a Feb. 11 public health advisory. The suspension involves only multidose vials of the drug, which have been linked to such severe allergic reactions as unresponsiveness, throat swelling and rapidly falling blood pressure. Reactions to bolus doses from multiple single-dose vials also have been reported, the FDA said in a MedWatch report.

Roughly 350 adverse events have been reported since the end of last year compared with fewer than 100 reports in 2007, the agency said. Approximately 40 percent of these reports appear to be serious adverse events.

The agency is working to identify alternate sources of heparin in case Baxter’s manufacturing suspension continues. Baxter provides approximately half of the U.S. supply of heparin.

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