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Deaths linked to heparin triple to 62

ByABC News
April 9, 2008, 12:08 AM

— -- The Food and Drug Administration has tripled the estimated number of people who may have died of allergic reactions associated with heparin, a blood thinner. The number now stands at 62, up from 19 a month ago.

"We've been continuing to get reports every single day," said the FDA's Karen Riley.

The new death count reflects deaths that occurred between January 2007 and last month, most of which were reported after the FDA announced it was investigating contaminated heparin in February.

The FDA said last month that a cheap heparin substitute made from animal cartilage was used to supplement real heparin imported from China and used in heparin products from Baxter International. Scientists have not yet been able to trace how the substitute might be causing the allergic reactions.

Raw heparin is made from the inside of pig intestines and is primarily produced in China.

The death counts the FDA announced Tuesday cover allergic reactions associated with heparin made by all manufacturers.

A very low level of allergic reactions to heparin is well known and noted in the product literature, said Riley.

The number of patients taking heparin who died and had at least one allergic symptom hovered between zero and two from January of last year through October 2007. But in November, it jumped to eight, then 12 in December, rising to 16 in January and falling to 11 in February.

There were no deaths in March, the month after Baxter recalled the bulk of its heparin products.

For all of 2006, there were three deaths reported in patients receiving heparin who had at least one allergic symptom, the FDA says.

The agency continues to receive adverse event reports about heparin, Riley says.

However, reports of allergic symptoms do not mean they caused the patients' deaths in all cases, according to the FDA.

Baxter spokeswoman Erin Gardiner says it's not unusual for adverse events reports to build as publicity spreads about possible problems associated with drugs. Those reports typically come from the manufacturers or physicians.