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More Serzone-Related Deaths Reported by Consumer Group


WASHINGTON (Reuters) Oct 29 - 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.

http://www.medscape.com/viewarticle/463707?mpid=20503