B-MS to add warning to Serzone labeling

Bristol-Myers Squibb has been instructed by the US Food and DrugAdministration to add a black-box warning to the labeling for its antidepressant drug Serzone (nefazodone) to indicate that cases of liver failure have been associated with use of the product. B-MS has also been asked to send out letters to physicians to draw attention to this potential side effect.

The development in the USA follows a similar warning sent out earlier this year in Canada.

Serzone is a combined serotonin/norepinephrine reuptake inhibitor that has found a niche in the antidepressant market as it is considered to be less prone to causing sexual side effects than the main SSRI class. Turnover of the drug in 2000 was around $400 million, according to the Wall Street Journal.