U.S. Allows Continued Sale of Abbott Weight-Loss Drug
Aug 18, 2005
The Food and Drug Administration has decided that Abbott
Laboratories can continue to sell its weight-loss drug
Meridia, ruling against a consumer group's argument
that the drug should be banned for safety reasons.
But the F.D.A. did ask the company to remind doctors
that people with known cardiovascular problems should
not take the drug.
The F.D.A. ruling, which Abbott announced yesterday,
was in response to a petition filed in 2002 by the Health
Research Group of the consumer advocate organization
Public Citizen. The group asserted that Meridia was
related to stroke and heart attacks. The petition cited
records at the F.D.A, which had received reports of
30 deaths and 224 cases of serious but not fatal cardiovascular
problems in Meridia patients from 1997 through late
summer 2003.
In an Aug. 9 letter denying the group's petition, the
F.D.A. noted that heart attacks and strokes were frequently
linked to obesity. While it was plausible that Meridia
could be causing the problems, the letter said, the
existing data made it impossible to conclude that patients
taking Meridia suffered them at a rate higher than overweight
people generally.
The letter, signed by Dr. Steven K. Galson, the agency's
acting director for drug research and evaluation, said
the agency was monitoring a Meridia clinical trial in
Europe. That study, involving 9,000 overweight patients,
will compare the rate of heart attacks and strokes in
Meridia patients with those taking a placebo.
In Senate testimony last year, an F.D.A. safety officer,
Dr. David Graham, listed Meridia as one of five potentially
dangerous drugs the agency should review. Since then,
the agency has taken some type of action or rendered
findings on all five of the drugs.
Bextra, the Pfizer painkiller, was ordered withdrawn
from the market in April. Crestor, the anti-cholesterol
drug manufactured by AstraZeneca, was allowed to remain
on the market. The F.D.A. required new restrictions
on the use of Accutane, an acne medication by Roche
Holding known to cause birth defects. And an F.D.A.
advisory panel ruled that the asthma drug Serevent,
by GlaxoSmithKline, should remain on the market.
Dr. Galson also said that the use of Meridia
by obese patients carried a number of benefits besides
weight loss. He cited one clinical trial that found
Meridia helped patients lose weight - with 70 percent
losing 5 percent or more of their weight and 46 percent
losing 10 percent or more - and also lowered cholesterol
and reduced the need for diabetes medications in many
patients.
Responding to the F.D.A. ruling, Dr. Sidney Wolfe of
the Health Research Group said his organization would
continue to sound the alarm, even though Meridia had
sales of only $60 million last year in the United States,
which, he said, is evidence of a 60 percent decline
in prescriptions since 2001.
"The public is sort of running away from the drug,"
Dr. Wolfe said yesterday. "But still, a lot of
people are getting it. Deaths are continuing to occur.
There's no evidence in the long run that it works. When
people stop using it, their weight goes back up."
In a statement yesterday, Abbott Laboratories said
Public Citizen's petition had "unnecessarily alarmed
and misled patients." The company said it had already
sent out a letter to doctors early this year and changed
the drug's label to emphasize that Meridia should not
be used in patients with cardiovascular problems.
Some doctors have said that for many patients the weight
loss from taking Meridia is not substantial enough to
justify its cost, which is about $90 a month and is
often not paid by prescription drug plans. Meridia is
more widely used abroad, where it is sold under the
name Reductil. Foreign sales of the product reached
$240 million last year. That is a small fraction of
Abbott's net sales of $19.6 billion last year.
Source: http://www.nytimes.com
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