FDA tells Bristol-Myers to add black box Serzone warning--WSJ

[Guest guest]

FDA tells Bristol-Myers to add black box Serzone warning--WSJ

10th December, 2001

Wall Street Journal

NEW YORK (Reuters) - The US Food and Drug Administration 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) informing patients

that rare but perhaps life-threatening liver damage can occur when using the

drug, The Wall Street Journal said 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 FDA estimated the reported rate in this country is about one case of

liver failure for every 250,000 to 300,000 patients using the drug for one

year, the newspaper said.

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 said.

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. It noted that Serzone does about $400

million in annual sales.

Copyright © 2001 Reuters Limited

[Guest guest]

FDA tells Bristol-Myers to add black box Serzone warning--WSJ

10th December, 2001

Wall Street Journal

NEW YORK (Reuters) - The US Food and Drug Administration 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) informing patients

that rare but perhaps life-threatening liver damage can occur when using the

drug, The Wall Street Journal said 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 FDA estimated the reported rate in this country is about one case of

liver failure for every 250,000 to 300,000 patients using the drug for one

year, the newspaper said.

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 said.

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. It noted that Serzone does about $400

million in annual sales.

Copyright © 2001 Reuters Limited