The FDA now requires Bristol-Meyers to include warnings on all product
inserts and consumer information packets regarding Serzone liver damage. Doctors are
required to advise their patients about the liver damage risks associated with this
medication. Consumer safety groups are urging the FDA to ban Serzone due to its potential for liver damage. The "liver damage" warning was added to an already lengthy list of harmful Serzone side effects and other problems identified in pre-marketing trials of Serzone. Worldwide, 3,496 patients participated in the trials, but some 16 percent of them had to drop out because of adverse reactions.
On December 7, 2001, the U.S. Food and Drug Administration told Bristol-Myers Squibb, makers of the antidepressant Serzone (nefazodone), that the company must provide a warning label about possible life-threatening liver damage resulting from use of the drug. On January 8th, 2003, Serzone was removed from the market in all European countries because it has been linked to 26 deaths from liver damage. This follows a black box warning issued by the FDA in 2001. In the USA, it has not been removed from the market. Therefore, patients taking nefazodone who are experiencing Serzone side effects suggesting possible liver damage should contact a physician right away. Such symptoms include:
- unusual tiredness
- stomach or abdominal pain, and /or
- loss of appetite.
In an effort to compensate the victims for Serzone liver damage,
Serzone litigation has been filed on behalf of people who have suffered
as a result of the side effects of Serzone.