Drug Warning: Serzone

Generic name: nefazodone hydrochloride

Manufactured and marketed by: Bristol-Myers Squibb

Purpose: Was prescribed to treat people suffering from depression.

Side Effects Reported

• Bisphosphonates Serzone was linked to multiple cases of severe liver damage and liver failure in some patients to whom it was prescribed.
• A number of the liver problems believed to be caused by Serzone led to the need for a liver transplant or, at worst, resulted in death.

Industry Report

Company withdrew drug from market in 2004. As reports of Serzone causing severe liver damage came about, the FDA took steps to warn physicians and patients of the dangerous side effect. In 2002, Serzone was required by the FDA to have a "black box warning" concerning liver damage, added to its packaging. The black box warning is the strongest warning available to the FDA without banning a drug from the market.

The group Public Citizen reported that even after the black box warning was implemented, the number of people suffering from liver failure linked to Serzone continued to rise. Some reports have Serzone associated with as many as 55 cases of liver failure and 39 separate cases of severe liver damage. At least 20 deaths have been associated with liver failure from Serzone.

Seeger Weiss is not currently pursuing lawsuits on this drug, but its drug warnings will remain on our radar.

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