Serzone is an antidepressant medication developed by Bristol-Myers Squibb, which was approved for sale in the United States in 1994. Serzone was often prescribed for depression combined with anxiety.
Following reports of liver failure in Serzone users, the FDA required Bristol-Myers to place a "black box" warning on Serzone's packet insert.
Serzone was withdrawn from the market in Europe in January, 2003, and in Canada in November, 2003.
In early 2004, the safety watchdog organization Public Citizen filed a lawsuit intended to force the FDA to withdraw Serzone from the market.
In May, 2004, Bristol-Myers announced that it would stop manufacturing Serzone for "business" reasons, although it continues to insist that the drug was perfectly safe.