FDA pressured to Ban Serzone NOW, as Canada's ban.goes into effect!

X-No-Archive: yes

http://www.citizen.org/hot_issues/issue.cfm?ID=664

Oct. 29 - New reports of deaths, injuries from antidepressant Serzone; FDA
should ban now

FDA Should Follow Lead of Europe; Canada, Remove Drug from Market, Public
Citizen Says

New reports of deaths and severe injuries from liver failure in patients
taking the antidepressant Serzone (nefazodone) require that the U.S. Food
and Drug Administration (FDA) act immediately to protect U.S. patients,
Public Citizen said today.

Ban the Anti-Depressant Serzone

http://www.citizen.org/pressroom/release.cfm?ID=1567

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON - The antidepressant Serzone, about to be pulled off the market
in Canada and long gone in Europe, should be banned in the United States
because of cases of deadly liver failure, a consumer advocacy group told the
government Wednesday.

It's impossible to predict which patient will develop liver failure, an
unacceptable risk considering Serzone works no better than older
antidepressants that don't come with that side effect, Dr. Sidney Wolfe of
Public Citizen told the Food and Drug Administration.

The United States is "lagging behind other countries in drug safety," Wolfe
wrote the FDA. "Remove this drug from the market before more people are
injured or killed."

Wolfe's petition details 55 cases of liver failure, including 20 deaths, and
another 39 cases of less severe liver injury reported to the FDA since
Serzone began selling in 1994. Rather than trickling off as the years
passed, side-effect reports are increasing since the FDA two years ago
placed its strongest possible warning on Serzone's label to alert patients
to the risk, Wolfe said.

The FDA estimates its monitoring system counts fewer than 10 percent of the
side effects caused by medications, meaning far more Serzone users may have
been harmed, Wolfe said.

Public Citizen first asked FDA to ban Serzone in March, and the agency
refused. Wednesday, the consumer advocacy group asked again, citing
international concern:

_Earlier this month, Canadian authorities announced Serzone would be pulled
off the market, saying, "to date, no risk factor to predict patients who
will develop irreversible liver failure ... has been identified." Nor have
traditional measures, like routine liver tests, reduced that risk, Health
Canada concluded.

To give patients time to switch to another medicine, Serzone sales in Canada
will end on Nov. 27.

_The World Health Organization and Health Canada recently compared a number
of popular antidepressants and found only Serzone linked to an increased
risk for serious liver injury, Wolfe said.

(***FDA depraved indifference to human life.)

While the FDA will examine Wolfe's petition, for now it contends that
warning patients about the risk is adequate, particularly as liver failure
is a rare risk.

"Depression is a serious illness. Not all patients respond to all drugs,"
said Dr. Thomas Laughren, FDA's antidepressant chief. "We think clinicians
and patients should have options."

Manufacturer Bristol-Myers Squibb Co. says cases of liver failure among
Serzone users are very rare and side-effect rates haven't changed,
suggesting no need for renewed concern.

"We respectfully disagreed with Health Canada" about the liver risk, but
ultimately bowed to regulators' wishes to end sales there, said
Bristol-Myers spokesman Rob Hutchinson. Here, "there is no new data that
would alter the risk-benefit assessment of the product."

Bristol-Myers quit selling Serzone in Europe last January, saying it made
the decision because of low sales, not safety questions. But some foreign
regulators cited concern about fatal liver failure at the time, and Wolfe
said sales in Scandinavia and Turkey have since ended, too.

Wolfe said Serzone, known chemically as nefazodone, inhibits an enzyme key
to drug metabolism, allowing the antidepressant to sometimes build to toxic
levels in the liver. That enzyme also metabolizes numerous other drugs,
meaning patients taking multiple medications could be at higher risk, he
said.






-- 
US Code Title 18 Section 873. Blackmail

   " Whoever, under a threat of informing, or as a consideration for
    not informing, against any violation of any law of the United
    States, demands or receives any money or other valuable thing,
    shall be fined under this title or imprisoned not more than one
    year, or both."