FDA Updates Likely Heparin Death Toll

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The FDA has released new information on the number of reported heparin-related deaths and the subset of deaths associated with allergic or hypotensive symptoms since January 2007. According to the FDA, there have been 103 reported deaths since the beginning of 2007, 91 (88%) of which were reported during 2008. Among these deaths, 62 (60%) were associated with one or more allergic or hypotensive reactionsthe kinds of reactions that led to the recent recall of Baxter's heparin; 56 of the 62 were reported during 2008. The FDA advises that the presence of allergic or hypotensive symptoms does not necessarily indicate a cause of death.

 

FDA_heparin_deaths2.jpgAlso according to FDA records, there were 55 heparin-associated deaths during 2006 in individuals with "a variety of underlying medical conditions." Only 3 were reported to be associated with allergic or hypotensive events.

*Heparin from any manufacturer.

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This page contains a single entry by bmartin published on April 9, 2008 9:52 AM.

FDA to GSK: How Widespread Are Your Reporting Deficiences? was the previous entry in this blog.

Another ENHANCE Panel: Still No Discussion of "Missing" or "Implausible" Data is the next entry in this blog.

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