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Serzone Alert

The FDA has issued a warning that cases of life-threatening hepatic failure have been reported in patients using nefazodone hydrochloride (Serzone), a treatment for depression. Over 109 cases of serious liver injuries allegedly associated with Serzone have been reported. In at least 23 cases, Serzone users experienced liver failure and 16 underwent a liver transplant and/or died. Bristol-Myers Squibb, the manufacturer, admits that liver failure rates are 3-4 times greater for Serzone users than non-users. The FDA estimates that the reported rate of liver failure in Serzone patients who used the drug for at least one year is about one case in every 250,000 to 300,000.

Pursuant to the FDA's directives, Bristol-Myers Squibb has now updated its warnings to both consumers and healthcare practitioners. Patients taking Serzone should be advised to report signs and symptoms of liver dysfunction such as jaundice, anorexia, or gastrointestinal complaints to their physician immediately. If they develop evidence of hepatocellular injury, such as increased serum aspartate aminotrasferase or serum alanine at levels three times or higher than the upper limit of normal, they should be withdrawn from the drug and should not be considered for re-treatment.

Serzone was approved by the FDA for use in the United States for the treatment of depression in 1994. An anti-depressant in a class of its own in terms of its structure and composition, Serzone shares some characteristics with other serotonin uptake inhibitors like Prozac, Paxil and Zoloft. Serzone generates annual sales of $400 million for Bristol-Myers.

We are investigating reports that Bristol-Myers Squibb failed to warn users of a known danger that the drug could cause life-threatening liver damage. For further information on the continuing investigation into the failure of Bristol-Myers Squibb to warn users of the dangers of Serzone, or to discuss your rights as a user of the drug (whether or not you have suffered ill effects), please call us toll free at 888-733-3572.