Petition To
Ban Diet Drug Renewed
By Marc Kaufman
Washington Post Staff
Writer
Thursday, September 4, 2003; Page
A08
The consumer advocacy group Public Citizen said yesterday
the diet drug Meridia has been associated with the deaths of 49
patients since it came on the market five years ago, as the group
renewed a petition to the Food and Drug Administration to have the
drug banned.
Public Citizen, which initially petitioned the FDA
regarding Meridia more than a year ago, supplemented its effort with
new information from the FDA "adverse event" database through the
end of March. In addition to the 49 deaths, Public Citizen said 124
users have been hospitalized for serious heart and cardiovascular
problems since the drug was approved.
"There is no justification in continuing to market a drug
that provides minimal weight reduction while increasing the
likelihood of injury and death," the petition said. Many of the
newly reported deaths, the petition said, were of people younger
than 50.
Sidney Wolfe, director of Public Citizen's Health Research
Group, said he had been told that the FDA is studying whether
weight-loss drugs such as Meridia, which contain amphetamine-like
compounds, cause more heart and cardiovascular disease than other
weight-loss medications.
FDA spokeswoman Laura Bradbard said that after the initial
Public Citizen petition, the agency began an additional review
comparing adverse event reports for Meridia and for Xenical, another
major weight-loss drug that doesn't have amphetamine-like
components. She said no date had been set for a decision on the
petition.
Meridia's manufacturer, Abbott Laboratories, said the drug
is safe and has been used by more than 12 million people worldwide.
Fewer than 1 million Meridia prescriptions are written annually in
the United States, a company spokeswoman said.
"Sidney Wolfe's supplement to the March 19, 2002, Citizen's
Petition to the FDA reflects a pattern of irresponsible conduct by
Public Citizen," the company said in a statement. "The safety of
Meridia has recently been comprehensively re-examined by regulatory
authorities, including the European Committee for Proprietary
Medicinal Products and Canadian Health authorities, and [they] have
concluded that the risk/benefit profile of Meridia remains
favorable. . . . Obese patients are at serious risk for premature
death and cardiovascular complications."
Because overweight people have a greater risk of heart
attack and cardiovascular disease, the debate now is whether Meridia
increases that risk. In its safety information on Meridia, the
company says that the drug "substantially increases blood pressure
in some patients" but also that weight loss with Meridia can
decrease cardiovascular risks.
But Wolfe said, "It's clear this drug increases the risk of
death."
Meridia has avid supporters, who say it has helped them
lose significant weight. But in its petition, Public Citizen said
the average weight loss announced at the drug's approval was 61/2
pounds after a year of taking 10 milligrams daily. The petition also
said cardiovascular birth defects were reported in four babies born
to women taking the drug.
Last year, the FDA reprimanded Abbott for not properly
reporting the deaths of patients taking Meridia. The agency said
information about seven deaths was not reported properly, one death
was not reported at all and reports on three other deaths were
incomplete. Abbott acknowledged the error but said it occurred
before it owned the drug, which was developed by Knoll
Pharmaceuticals.
© 2003 The Washington Post
Company
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