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FDA Links More Deaths to Blood Thinner
Tuesday April 8, 6:51 PM EDT
WASHINGTON (AP) — 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.
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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.
http://finance.myway.com/jsp/nw/nwdt_rt.jsp?section=news&feed=ap&src=601&news_id=ap-d8vtvf680&date=20080408
Tuesday April 8, 6:51 PM EDT
WASHINGTON (AP) — 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.
~
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.
http://finance.myway.com/jsp/nw/nwdt_rt.jsp?section=news&feed=ap&src=601&news_id=ap-d8vtvf680&date=20080408