FDA Advisers Divided on Whether to Ban Diet Drug
WEDNESDAY, Sept. 15 (HealthDay News) -- U.S. health advisers
were split Wednesday over whether the diet drug Meridia should be
pulled from the market, because of evidence that it increases the
risk of heart attack and stroke.
Members of an advisory panel to the U.S. Food and Drug
Administration who said the drug should remain available to
consumers called for new warnings and restricted distribution of
the drug, the
Associated Press reported.
While the FDA is not bound to follow the recommendations of its
advisory committees it typically does so.
European regulators banned the drug earlier this year, the
In documents released Monday ahead of the panel meeting, the FDA
said that members of its Endocrinologic & Metabolic Drugs
Advisory Committee would be asked to consider a number of options,
including taking no action, adding label warnings and/or
restrictions to the use of Meridia, or to withdraw Meridia from the
U.S. market. The drug is made by Illinois-based Abbott
The meeting comes on the heels of a study released earlier this
month that linked the drug to an increased risk of nonfatal heart
attacks and stroke, although taking the drug did not seem to up the
risk of death in patients with a history of heart problems.
The trial involved almost 11,000 older, overweight or obese
adults with type 2 diabetes or heart disease or both who were
randomly chosen to take either Meridia or a placebo and followed
for about 3.4 years.
In the group taking Meridia, 11.4 percent had a heart attack,
stroke or died as the result of a heart problem, versus 10 percent
in the control group, a 16 percent increase.
People taking Meridia also had a 28 percent higher risk for
nonfatal heart attack and a 36 percent raised risk for nonfatal
stroke, compared to those taking a placebo, the researchers
The study stirred mixed reactions from experts.
According to the authors of the trial, which was funded by
Meridia's maker, Abbott, the findings were generally in line with
what has been known about the drug and shouldn't change how it is
"The only time you've got an increase in heart attacks or strokes were in those patients who had had previous heart disease or strokes, in other words, the people who . . . should never have received the drug in the first place," said Dr. Philip T. James, a professor at the London School of Hygiene and Tropical Medicine in England, and first author on the paper, which was published in the Sept. 2 issue of the New England Journal of Medicine.
Since January, Meridia (sibutramine) has carried a label warning
that it should not be used by people with preexisting heart
disease, so "the current prescription is entirely appropriate,"
However, not everyone agreed.
According to Dr. Greg Curfman, executive editor of the
NEJM and co-author of an accompanying editorial, the FDA's
January warning was based on preliminary information only. The new
study results represented the first hard data, "the first outcomes
trial," he said.
Based on the findings, he and others wondered if the drug was
worth keeping around.
The drug did not seem to make people healthier, Curfman said.
"Some people were actually made worse," he said. "All this taken
together results in an unfavorable risk-benefit profile and, based
on that, we don't see a rationale for keeping this on the
Also, he said, "the efficacy of producing weight loss with the
drug is very unimpressive. In this trial, patients lost on average
less than 4 kilograms [about 9 pounds] and we know that that's not
going to translate into a real health benefit over time. It's not
enough weight loss. The FDA has a benchmark of about 5 percent loss
of baseline body weight to consider a weight-loss drug
Another expert agreed that relying on any pill for substantial
weight loss may be unrealistic.
"Good old-fashioned diet and exercise is the only substantive sustained therapy that's shown to be helpful," said Dr. J. Chad Teeters, an assistant professor of clinical medicine, cardiology division at the University of Rochester Medical Center in New York. "There's no quick-fix pill."
There's more on Meridia at the
U.S. National Library of Medicine.
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