Bristol Myers Squibb Takes Serzone off the market on June 14_AP

[Guest guest]

DARocksMom

Thu, 20 May 2004 06:15:49 EDT

Fwd: Bristol Myers Squibb Takes Serzone off the market on June 14_AP

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting openness and full disclosure

http://www.ahrp.org

 

 

FYI:

The antidepressant Serzone, TAKEN OFF THE MARKET as of June 14 (for " business

reasons " the company says).

 

The drug was already taken off the market in Europe, Australia, New Zealand and

Canada. In the case of Canada, because of " adverse events including liver

failure. " However, the company continued to sell the drug in the US.

 

" The FDA has received reports of at least 55 cases of liver failure, including

20 deaths, and another 39 cases of less severe liver injury since Serzone began

selling in 1994. In 2002, the FDA added to Serzone's label its strongest type of

warning about the liver risk, maintaining that liver toxicity is a rare risk

adequately managed by warning patients. "

 

Public Citizen was in the process of suing the FDA the agency had not responded

to its petition asking for a ban.on Serzone.

 

Hundreds more victims and families are suing its maker Bristol Myers Squibb.

 

CBS news had aired a story of one such victim: Cassie Geisenhof who was just 15

when she was prescribed Serzone for depression.

Three months later, she suffered irreversible liver damage and got a transplant

but never recovered. She died last month.

 

This does not quite end the controversy, as generic versions of the drug are

still on the market and Public Citizen will continue to sue the FDA over this

issue if the generics aren't also pulled.

 

Statement from Bristol Myers:

 

" For commercial reasons we're discontinuing sales and manufacture of Serzone

effective June 14.We decided to discontinue sales of the product specifically

because there's currently a wide availability of the product through generic

companies in the US and we've seen a rapid decline of the volume of branded

sales. " The company denies adverse events played any role in the withdrawal,

even though the company acknowledged that was the case in the Canada withdrawal.

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

 

 

 

 

 

 

 

Health News

 

Maker to pull antidepressant off market

 

By LAURAN NEERGAARD

The Associated Press

5/19/2004, 4:55 p.m. ET

 

 

WASHINGTON (AP) — The maker of Serzone will pull the controversial

antidepressant off the U.S. market next month, blaming a decline in sales rather

than concern about a risk of liver failure.

 

The end to U.S. sales comes after Serzone was pulled off the market in many

other countries, and as maker Bristol-Myers Squibb was under mounting pressure

from lawsuits. Serzone has been linked to dozens of cases of liver failure and

injury, including at least 20 deaths.

 

A Bristol-Myers spokesman confirmed the decision in an interview Wednesday, a

day after the company notified wholesalers that distribution would end June 14.

 

The end to sales " is long overdue, " said Dr. Sidney Wolfe of the consumer group

Public Citizen. " None of the other antidepressants causes liver damage like

this. "

 

Wolfe last spring sued the Food and Drug Administration seeking to force a ban

on Serzone. That suit will proceed in an effort to also end sales of generic

versions of Serzone, called nefazodone, Wolfe said.

 

An Alabama attorney said he would ask the company and the FDA to go a step

further and recall Serzone, saying that patients shouldn't continue to buy and

use the pills between now and June 14.

 

" I really think that's a ploy to take the heat off, " said Jere Beasley, an

attorney in Montgomery, Ala., representing 30 families in Serzone lawsuits.

" It's not going to solve the problem. "

 

Bristol-Myers spokesman Rob Hutchison said that the decision had nothing to do

with safety questions and that the company would continue to vigorously defend

the pending lawsuits.

 

" We still believe, and I believe the FDA does, too, as well as physicians, that

nefazodone is an important therapeutic option for patients with depression, "

Hutchison said.

 

Instead, the company is discontinuing Serzone because of rapidly declining sales

after generic competitors hit the market last year, he said. " Our market share

is very small. "

 

Sales of 16 other very old products also will cease, he added.

 

Bristol-Myers ended Serzone sales in Europe over a year ago, citing declining

sales. Canadian regulators banned the drug last fall because of the liver risk.

Sales in Australia and New Zealand are about to end, too.

 

The FDA has received reports of at least 55 cases of liver failure, including 20

deaths, and another 39 cases of less severe liver injury since Serzone began

selling in 1994. In 2002, the FDA added to Serzone's label its strongest type of

warning about the liver risk, maintaining that liver toxicity is a rare risk

adequately managed by warning patients.

 

But Wolfe notes that the World Health Organization and Canadian regulators last

year compared a number of popular antidepressants and found only Serzone was

linked to an increased risk of serious liver injury.

 

Canadian authorities said they banned the drug because there was no way to

predict which patients would be at risk for liver failure. Routine liver tests

haven't reduced that risk, they said.

 

Copyright 2004 The Associated Press. All rights reserved

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has

not always been specifically authorized by the copyright owner. Such material is

made available for educational purposes, to advance understanding of human

rights, democracy, scientific, moral, ethical, and social justice issues, etc.

It is believed that this constitutes a 'fair use' of any such copyrighted

material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law.

This material is distributed without profit.

 

 

 

 

 

 

 

Domains - Claim yours for only $14.70/year