Serzone is a drug manufactured by Bristol-Myers Squibb Co.used to treat depression. Serzone was first introduced to the U.S. market with no warning of liver toxicity, although pre-clinical trials indicated the possibility of liver damage in some patients. The FDA subsequently required Squibb to include a warning on the label. The new label warned of “rare reports of liver necrosis and liver failure, in some cases leading to liver transplantation and/ or death.” Six months later, the FDA required Squibb to remove the word “rare” from the warning statement, and finally to place a “Black Box” warning on the safety label. Less than a month later, Bristol-Myers Squibb advised health care providers that Serzone had been associated with cases of life-threatening liver failure.
The side effects of Serzone include jaundice, dark colored urine, loss of appetite, yellowing of the whites of the eyes, nausea, abdominal pain, and physical discomfort or uneasiness. Users of Serzone should consult a doctor for an evaluation. There has been at least one class action suit filed against the manufacturers of Serzone.