WASHINGTON – The Food and Drug Administration has tripled the number of deaths it attributes to side effects of the blood thinner heparin, which triggered a massive recall earlier this year.
The agency has been investigating contamination of heparin made by the manufacturer Baxter International Inc., which it linked to 19 deaths and hundreds of allergic reactions.
After reviewing adverse events back to January 2007, FDA said Tuesday it uncovered 103 reports of patients who died while taking heparin.
Of those deaths, 62 involved allergic reactions or hypotension, a type of dangerously low blood pressure. Those are the same side effects that caused Baxter's to pull all U.S. heparin injections from the market by February.
The agency's month-by-month figures include deaths of patients taking heparin made by various manufacturers, not just Baxter's.
FDA received 55 reports of death with the blood thinner in 2006, but only three were due to allergic reactions.
FDA spokeswoman Karen Riley said the agency decided to release the additional numbers on heparin deaths at the request of consumers. Previous agency announcements were limited to adverse events recorded in 2008.
Riley said the drug has long carried warnings of low blood pressure risks, which likely contributed to deaths seen in prior years.
A Baxter spokeswoman said the Deerfield, Ill.-based company has identified only four deaths to date where its recalled heparin may have played a role. FDA's numbers include reports from additional sources, including other manufacturers.
Another manufacturer, APP Pharmaceuticals Inc., said there have been no reports of death with its product due to the allergic reactions cited by FDA. The agency found no contamination in heparin batches made by the Schaumburg, Ill.-based company.
Heparin is derived from a mucous obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops in China.
FDA determined last month that Baxter's drug was contaminated with an unnatural chemical during production at a plant in China. The agency is still investigating whether the chemical was added accidentally or deliberately.
Shares of Baxter International Inc. fell 61 cents, or 1 percent, Tuesday to close at $59.83. Shares of APP Pharmaceuticals Inc. rose 6 cents to close at $13.