Health
Antidepressant withdrawn from U.S. market
NEWS IN BRIEF — Posted June 7, 2004
Officials from Bristol-Myers Squibb announced May 18 that the company will end wholesale distribution of the antidepressant Serzone, or nefazodone, as of June 14 because of declining sales.
The drug, which is available as a generic, has been taken off the market in other countries and is the subject of several lawsuits in the United States that charge it causes liver damage.
Bristol-Myers has said the drug was safe and that it intends to continue to defend itself against the lawsuits.
The advocacy group Public Citizen sued the Food and Drug Administration in March over the agency's failure to act on a petition filed by the group last year seeking a ban of nefazodone, citing 21 cases of liver failure and 11 deaths between 1994 and 2002 that it blamed on the drug.
Public Citizen also faulted Bristol-Myers Squibb for not issuing a recall of the drug instead of merely withdrawing it, leaving the drug still available to patients.
The drug was approved in 1994 and has had a black box warning of liver failure since January 2002.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/06/07/hlbf0607.htm.
