Big victory!!! Maker to pull antidepressant off market

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Maker to pull antidepressant off market

By LAURAN NEERGAARD

The Associated Press

5/20/2004, 10:39 a.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. This material may not

be published, broadcast, rewritten or redistributed.

[Guest guest]

http://www.mlive.com/newsflash/lateststories/index.ssf?/base/politics-0/10850642\

78237130.xml

Maker to pull antidepressant off market

By LAURAN NEERGAARD

The Associated Press

5/20/2004, 10:39 a.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. This material may not

be published, broadcast, rewritten or redistributed.

[Guest guest]

http://www.mlive.com/newsflash/lateststories/index.ssf?/base/politics-0/10850642\

78237130.xml

Maker to pull antidepressant off market

By LAURAN NEERGAARD

The Associated Press

5/20/2004, 10:39 a.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. This material may not

be published, broadcast, rewritten or redistributed.

[Guest guest]

http://www.mlive.com/newsflash/lateststories/index.ssf?/base/politics-0/10850642\

78237130.xml

Maker to pull antidepressant off market

By LAURAN NEERGAARD

The Associated Press

5/20/2004, 10:39 a.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. This material may not

be published, broadcast, rewritten or redistributed.