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Study finds commonly prescribed heart and stroke medication problematic

graphic

April 20, 2000
Web posted at: 1:02 p.m. EST (1702 GMT)

BOSTON (CNN) -- A commonly prescribed anti-clotting drug has been found to have dangerous side effects, according to a study released early by the New England Journal of Medicine (NEJM).

Clopidogrel has been hailed as one of the most effective drugs in reducing risk of heart attack and stroke caused by artherosclerosis, in which the wall of an artery thickens and loses elasticity. An estimated 3 million people have been treated with the drug worldwide.

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Researchers report the drug clopidogrel may be associated with a disorder called thrombotic thrombocytopenic purpura (TTP). TTP causes small blood clots to form throughout the body, leading to symptoms like jaundice, abnormal heart rhythm, and organ damage.

If not treated, TTP is almost always fatal, but with treatment, more than half of those affected survive.

  ABOUT CLOPIDOGREL
  

Souce: Davis's Drug Guide for Nurses

 

The study found 11 patients who developed TTP within two weeks of taking clopidogrel. The article says one of those patients died after diagnosis.

The authors do not know if the drug caused the TTPs. But they say doctors who prescribe clopidogrel need to know that TTP is a possible side effect so they can watch for the symptoms and treat them. They are not suggesting that doctors stop prescribing the drug.

Researchers say they will now be working with the drug company, Bristol-Myers Squibb, to develop further studies on the association and frequency of clopidogrel use and the occurrence of blood clots. In the meantime, the company is working with the Food and Drug Administration to change the package insert to include TTP as a possible side effect.

Previous studies found clopidogrel to be safe and even more effective than aspirin in reducing the risk of stroke and heart attacks, though it was not free of side effects. Known side effects included diarrhea and skin rashes.

NEJM released the study Thursday ahead of its scheduled June 15 publication date "because of the potential clinical implications," according to the journal.



RELATED STORIES:
Experimental drug edges aspirin in heart study
November 13, 1996

RELATED SITES:
Bristol-Myers Squibb
Food and Drug Administration Home Page
New England Journal of Medicine


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