Serzone concerns

Posted by Elayne on March 20, 2002, at 10:24:58

Hi everyone,
This is a response to a specific question from a few days ago, but I seem to have lost that thread.
Anyway, the FDA required Serzone to add a "black box" warning to its info to prescribers because of an observed incidence of 1 case of liver failure per 250,000 to 300,000 patient years. This is about 3 to 4 times the rate of liver failure expected without the drug.
You might try to access this web site for the details: www.fda.gov./medwatch/SAFETY/2002/serzone_deardoc.PDF.
Hope this helps.
Elayne

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Serzone concerns Elayne 3/20/02
Re: Serzone concerns beardedlady 3/20/02
Re: Serzone concerns Elayne 3/20/02
You're wonderful! Thanks! : ) (nm) » Elayne beardedlady 3/20/02

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