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FDA expanded analysis shows tripled fatal heparin reactions


Washington The Food and Drug Administration has stated that the number of deaths it is attributing to allergic reactions from the blood thinner heparin since January 2007 has more than tripled from 19 to 62, according to published reports. The agency noted though that these deaths weren’t new and that the new total is based on expanded analysis.

Problems with tainted heparin surfaced in the United States. in February, raising questions about the safety of the global supply chain for medicines and other products. Heparin, which is made from pig intestines, has been the subject of recalls in the United States as well as several countries in Europe.

Baxter International, one of the largest suppliers in the United States, and a German company have recalled heparin products that were found to be contaminated. German authorities and Baxter have said that the source of contamination appears to be in China, where ingredients for the heparin originated. Baxter's heparin may be linked to 19 of the 103 total number of deaths; that number includes other nonspecific reactions,  FDA spokeswoman Karen Riley said.

Baxter said it counts only four deaths possibly linked to its heparin. "There are zero patient deaths known to have been caused by the allergic-type reaction" cited in FDA reports, said Erin Gardner, a spokeswoman for Baxter.

The FDA said that there have been no new reports of deaths in March. "After the news about the contaminated heparin came out, suddenly we saw a huge bump in reports to us. But that is now leveling out," Riley said. Most of the deaths were reported between November 2007 and February 2008.

By contrast there were only three deaths due to allergic reactions to heparin in 2006, the FDA said.

The FDA has said that it hasn't determined whether the contaminant was accidentally or deliberately introduced into batches of heparin prepared for export in China.

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