Reuters Health Information (2003-10-29): More Serzone-related deaths reported by consumer group
More Serzone-related deaths reported by consumer group
Last Updated: 2003-10-29 16:26:43 -0400 (Reuters Health)
WASHINGTON (Reuters) - Nine more people who took Bristol-Myers Squibb's antidepressant Serzone (nefazodone) have died of liver failure since April 2002, a U.S. consumer group said on Wednesday, renewing its call for regulators to ban the drug.
Public Citizen said Serzone posed unacceptable risks of liver injury while offering no unique benefits compared with other antidepressants on the market.
A spokeswoman for the company was not immediately available for comment on Public Citizen's latest call for a ban, though in the past BMS has defended the drug.
The group first petitioned the Food and Drug Administration to ban Serzone in March. At the time, Public Citizen cited reports to the FDA of 53 cases of liver injury including 11 deaths among patients taking Serzone from December 1994 through March 31, 2002.
From April 1, 2002, through May 12, 2003, the FDA received nine additional reports of death from liver failure in Serzone patients, Public Citizen said in a letter sent Wednesday to FDA Commissioner Mark McClellan.
"The mounting number of deaths due to liver failure from a drug with no unique efficacy strongly argues for the removal of the drug from the market," the letter said.
Europe and Canada have already have banned Serzone, Public Citizen said.
Bristol-Myers has argued that Serzone was an important option for treating depression, and the company has worked with the FDA to point out rare instances of liver problems. Serzone's label includes a warning that the drug may cause liver failure.
Last month, several generic companies won approval to sell generic versions of Serzone.