Accutane

On January 9, 2002, Bristol-Myers Squibb Co. issued a manufacturer's warning advising health care providers that cases of life-threatening hepatic failure have been reported in patients treated with Serzone, an anti depressant drug. The warning indicates that numerous persons have or will suffer liver failure, and that current estimates of the rate of liver failure associated with Serzone use are about 3-4 times the estimated background of liver failure.

On December 7, 2001, the U.S. Food and Drug Administration told Bristol-Myer Squibb to include a so-called black box warning on labels of the anti-depressant drug Serzone® informing patients that life-threatening liver damage can occur when using the drug. Cases of liver failure leading to transplant and/or death in patients have been reported.

SERZONE Case Evaluation Form