Serzone is a prescription drug manufactured by Bristol-Myers-Squibb to treat depression. Unlike other antidepressant drugs, Serzone was marketed as an antidepressant that was less likely to decrease a user’s sexual drive. This marketing claim dramatically increased the product sales.
Since its approval by the U.S. Food and Drug Administration (FDA) on Dec. 22, 1994 , it is estimated that Serzone was prescribed and used by approximately 8.3 million people worldwide. In fact, Bristol-Myers reported worldwide sales of Serzone reached $409 million by 2001.
There have been 109 serious injury cases reported as a result of Serzone use since it first appeared on the market in 1994. Of those 109 serious injuries, 23 resulted in liver failure and 16 resulted in liver transplants. The onset of serious liver damage usually occurs within four months of starting treatment, and cases of liver injury have occurred as early as a few weeks after beginning treatment, or after continuous use for up to 1-2 years. In addition to the serious injuries that have occurred as a result of Serzone usage, there have been 13 deaths attributable to Serzone.
The possible side effects of Serzone include agitation, dizziness, clumsiness or unsteadiness, difficulty concentrating, memory problems, confusion, severe nausea, abdominal pain, unusually dark urine, difficult or frequent urination, fainting, skin rash or hives, yellowing of the skin or whites of the eyes (jaundice) or prolonged weight loss or loss of appetite.