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Serzone Linked to Serious Liver Problems

FDA Asked to Ban Nefazodone (Serzone)

WASHINGTON, DC-- March 14, 2003 -- The consumer advocacy group Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to ban the antidepressant nefazodone, marketed as Serzone by its manufacturer, Bristol-Myers Squibb. Prescribed for 4.5 million Americans, Serzone may cause severe liver problems. Its use has resulted in at least 53 liver injuries, including 21 liver failures and 11 deaths, according to the Public Citizen's analysis of government reports.

Periodic liver testing of patients taking nefazodone or Serzone does not prevent injury and doctors cannot predict who is at a high risk for liver damage. "There is no good reason to keep this drug on the market. It is no more effective than other antidepressants, and it presents a unique health hazard for patients," said Sidney Wolfe, M.D., of Public Citizen. The group cites a study in Spain showing that, of 13 antidepressants, nefazodone has the highest incidence of liver injury -- seven to 22 times that of other antidepressants.

Warnings about Nefazodone or Serzone

Bristol-Myers Squibb removed nefazodone from the European market after the Swedish Medical Products Agency announced that it would require a warning on the drug's label about the potential for liver toxicity. In the United States, the FDA notified Bristol-Myers Squibb, that it must add a "black box" warning to the package insert for Serzone. The box warns that nefazodone may cause life-threatening liver damage and recommends that physicians advise their patients about the signs of liver problems. The Public Citizen petition says that the black box warning does not go far enough to protect patients, and asks that Serzone be taken off the market completely.

For more information about the side-effe. If you or a family member has been injured through the use of Serzone, please feel free to contact us to learn about your legal options. We have extensive experience in handling drug injury cases.

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