More MS news articles for Dec 2001

FDA says antidepressant must carry warning: paper

http://www.reutershealth.com/archive/2001/12/07/eline/links/20011207elin030.html

NEW YORK, Dec 07 (Reuters) - The US Food and Drug Administration (FDA) has told drugmaker Bristol-Myers Squibb Co. that it must include a so-called black-box warning on its label for the antidepressant Serzone (Nefazodone Hydrochloride) informing patients that rare but perhaps life-threatening liver damage can occur when using the drug, The Wall Street Journal reported on Friday.

The agency sent New York-based Bristol-Myers the notice this week and will soon require the company to warn doctors that a small number of patients could suffer from liver failure, leading to death or the need for a liver transplant, the newspaper said in its online edition.

The black-box designation refers to a black outline around a section of the label.

The FDA estimates the reported rate in the US is about one case of liver failure for every 250,000 to 300,000 patients using the drug for one year, the newspaper reported.

Serzone, known generically as nefazodone, brings in about $400 million in annual sales, it added.

The language the FDA will require on Serzone package labels will include warnings that "cases of life-threatening hepatic failure have been reported in patients treated with Serzone," The Wall Street Journal reported.

A number of US psychiatrists became concerned about the Serzone liver-failure problem after Canadian government authorities this summer issued a warning, the newspaper said.
 

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