MONDAY, Sept. 13 (HealthDay News) -- The U.S. Food and Drug
Administration will ask an expert panel later this week whether or
not the diet drug Meridia should be banned due to suspected heart
In documents released Monday ahead of the panel meeting, which
begins Wednesday, the agency said that members of its
Endocrinologic & Metabolic Drugs Advisory Committee will 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 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
randomized either to take 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 placebo, the authors found.
The study stirred mixed reactions from experts.
According to the authors of the trial, which was funded by
Meridia's maker, Abbott, the findings are 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, sibutramine (Meridia) 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 represent the first hard data, "the first outcomes
trial," he said.
Based on the findings, he and others wonder if the drug is worth
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. "There's no quick-fix pill."
There's more on Meridia at the
U.S. National Library of Medicine.
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