Posted by Tony C. on August 18, 2004, at 11:43:25
July 20, 2004
FDA ALLOWS GENERIC SERZONE TO REMAIN ON THE MARKET
The FDA has denied a citizen petition calling for the removal of Bristol-Myers Squibb's (BMS') antidepressant Serzone because of safety concerns — a move that allows generic firms to continue to market the drug, which no longer is sold by BMS.
BMS announced this spring it would stop marketing Serzone (nefazodone HCl) June 14 because generic versions are widely available and brand sales have rapidly declined. Several patient advocacy groups, however, have urged the FDA to remove all nefazodone products from the market because the drug has been associated with cases of serious liver toxicity.
The FDA, however, does not agree that the available evidence shows the drug is unsafe under approved conditions of use, the agency said in a response to a March 6, 2003, petition by the Public Citizen Health Research Group. "[The] agency continues to believe that nefazodone provides a potentially important alternative to other antidepressants and that, although there is a risk of liver injury associated with the drug, the incidence of liver failure appears to be low and is adequately addressed through product labeling," the FDA said in a recent letter linked to the agency's website.
Serzone has been associated with 94 cases of liver injury between December 1994 and May 2003, according to Public Citizen Health Research Group.
(NOW I DON'T FEEL SO ANXIETY RIDDEN OVER IF THEY ARE GOING TO BAN IT, I STILL WANT TO REDUCE, BUT THIS CALMS ME ALOT TO KNOW IT WAS NOT BANNED !!! HIP HIP HOORAY !!!)SINCERELY - HAPPY TONY C. ; )
poster:Tony C.
thread:379099
URL: http://www.dr-bob.org/babble/20040817/msgs/379099.html