TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug
Administration plans to take a second look at the weight loss pill
Qnexa on Wednesday, after initially rejecting it because of
concerns about heart problems and possible birth defects.
While effective at reducing weight, the drug, manufactured by
Vivus Inc., was denied approval in 2010 because of its potential
side effects. An FDA advisory panel will now review two years of
data; when advisers last voted on Qnexa, only one year's worth of
follow-up data was available.
The drug combines the appetite suppressant phentermine and the
anti-seizure/migraine drug topiramate. Phentermine was once widely
prescribed as the "phen" part of the fen-phen weight loss drug.
This combo was withdrawn from the market after its use was linked
to high blood pressure in the lungs and heart valve disease. The
problems were related to the "fen" or fenfluramine part of the
combination, not the phentermine.
No new weight-loss drug has been approved in the United States
in the past 13 years, according to published reports. As it stands,
Xenical is the only FDA-approved drug specifically for long-term
use -- up to a year -- for weight loss. Xenical is sold
over-the-counter as Alli. However, other drugs may be used off
label to promote weight loss.
Last April, a study funded by Vivus found that obese patients
taking Qnexa lost an average 22 pounds over a year, while also
lowering their blood pressure and cholesterol levels.
Dr. Louis Aronne, founder and director of the Comprehensive
Weight Control Program at New York-Presbyterian Hospital/Weill
Cornell Medical Center in New York City, is cautiously optimistic
that Vivus did a good job responding to FDA safety concerns, and
that the FDA will give the drug its nod of approval, with some
caveats. Aronne was not involved in the trials but has been an
adviser to Vivus and other companies developing weight loss
"I am not as pessimistic as most people," he said.
Vivus has reported that Qnexa may increase the risk of cleft lip
in babies of women who use the drug while pregnant. Aronne said the
birth defect concern could be addressed through education on who
should and should not use the new drug.
"We have learned our lessons with weight loss drugs," he said. "They need to be used in the right people under the right circumstances." The heart risks need to be weighed against reductions in heart disease risk factors that come with weight loss, he said.
Qnexa is not any riskier than bariatric surgery, according to
Aronne. "The problem is that it can be distributed more widely," he
said. He hopes for a compromise that allows the new compound to be
prescribed, but not misused. "Once new medications are approved,
local medical boards will need to enforce rules and make sure these
medications are prescribed appropriately to the right candidates,"
he said. "We don't want to open up pill mills."
One thing is clear, he said: More options to treat obesity are
needed. "For hypertension, there are 120 medications in nine
categories," Aronne said. "We need new options and we need to get
physicians thinking about obesity and obesity treatments."
Dr. Scott Kahan, an obesity expert at Johns Hopkins University
in Baltimore and director of the National Center for Weight and
Wellness in Washington, D.C., agreed. He is optimistic about the
FDA's upcoming decision on Qnexa. "The weight loss effects are
striking and approaching the amount of weight loss over two years
that we get with bariatric surgery," he said. "This is really
Learn more about
weight loss medications at the U.S. National
Institutes of Health.
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