CLDF Title
Home | Contact Us | Bookmark
About CLDF Centers of Educational Expertise  
Live CME Meetings Webcasts Slide Library Abstract Library Conference Highlights
Reuters Health Information (2003-10-29): More Serzone-related deaths reported by consumer group

Public Health

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.

Slide Library
Abstract Library
Slide Library
Abstract Library
Slide Library
Abstract Library
Slide Library
Abstract Library
Slide Library
Abstract Library
Slide Library
Abstract Library
CLDF Follow Us
About CLDF
Mission Statement
Board of Trustees
Board of Advisors
CLDF Sponsors & Supporters
Other Resources
Liver News Library
Journal Abstracts
Hep C Link to Care
Centers of
Educational Expertise
Substance Use Disorder
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2017 Chronic Liver Disease Foundation. All rights reserved. This site is maintained as an educational resource for US healthcare providers only.
Use of this Web site is governed by the Chronic Liver Disease Foundation terms of use and privacy statement.