Serzone Side Effects Prompt Canadian Recall

Bristol-Myers Squibb Discontinues Sale of Serzone in Canada

In an October 2, 2003 letter to health care professionals in Canada, Bristol-Myers Squibb announced that it will voluntarily discontinue sales of Serzone (nefazodone) in Canada effective November 27, 2003.

The letter from Bristol-Myers Squibb cites "hepatic adverse events such as jaundice, hepatitis, and hepatocellular necrosis," as well as "51 Canadian reports of hepatotoxicity ranging from no symptoms to transplantation suspected to be associated with nefazodone use" as of December 2002. The October 2, 2003 letter reiterates the content of an earlier June 20, 2001 letter from Bristol-Myers Squibb to Canadian healthcare professionals warning of serious hepatic events associated with Serzone.

The antidepressant drug nefazodone is sold under the name Serzone in the US, where its label carries a“black box” warning informing patients that rare but possibly life-threatening liver damage could result from use of the drug.

Serzone has already been recalled in Sweden, voluntarily withdrawn from the market in The Netherlands, and sales of Serzone (nefazodone) were discontinued in Europe.

Serzone is an antidepressant considered to be an alternative to other antidepressant drugs of the SSRI class, such as Zoloft, Paxil, or Prozac. Independent Spanish research showed Serzone to have the highest incidence of hepatic injury out of 13 antidepressants studied. The consumer advocacy group Public Citizen has petitioned the FDA to remove Serzone from the US market. Serzone now remains available on the market only in the US.