FDA Triples Heparin Death Count
Agency Attributes 62 Fatal Reactions Since January 2007
ALICIA MUNDY / Wall Street Journal 9apr2008
The Food and Drug Administration has tripled the number of deaths it attributes to allergic reactions to the blood thinner heparin since January 2007 to 62 from 19.
The FDA said these weren't new deaths, and that the tally is based on reports recently received by the agency as well as expanded analysis. The 62 fatality reports appear to match the type of allergic reactions that have been the main focus of safety concerns, the FDA said.
By contrast there were three deaths due to allergic reactions to heparin in 2006, the FDA said.
"What's really striking is the large number in such a short period of time," said Gerald Dal Pan, director of the office of surveillance and epidemiology at the FDA.
Heparin, which is made from pig intestines, has been the subject of recalls in the U.S. as well as several countries in Europe.
The FDA sent a letter to device manufacturers Tuesday, warning them to review their sources of heparin used in their products, such as heart stents. Some vascular stents and grafts, as well as devices used in pulmonary bypass and in-vitro diagnostic procedures, are coated with heparin.
"We're not talking about a large amount" of heparin in the devices, FDA spokeswoman Karen Riley said. On March 28, Covidien Ltd. initiated a nationwide recall of its prefilled lock flush syringes containing heparin as a precautionary measure.
Problems with tainted heparin surfaced in the U.S. in February, raising questions about the safety of the global supply chain for medicines and other products.
Baxter International Inc., one of the largest suppliers in the U.S., and a German company have recalled heparin products that were found to be contaminated. German authorities and Baxter have said the source of contamination appears to be in China, where ingredients for the problematic heparin originated.
Baxter's heparin may be linked to 19 of the 103 total number of deaths; that number includes other nonspecific reactions, said the FDA spokeswoman.
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," Ms. Riley said. Most of the deaths were reported between November 2007 and February 2008.
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.
source: p.A2 9apr2008