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February 23rd, 2012 
FAKE NEWS for the Zionist agenda WEDNESDAY, Feb. 22 (HealthDay News) — A U.S. Food and Drug
Administration advisory panel gave its blessing Wednesday to a highly
anticipated weight loss pill that had been rejected by health advisers
once before.
The committee of outside physicians voted 20-2 to back the drug Qnexa,
although the group urged that patients be monitored closely for potential
heart problems, the Associated Press reported.
A decision by the full FDA is expected in April. The agency typically
follows the recommendations of its advisory panels.
While effective at reducing weight, the drug, manufactured by Vivus
Inc., was denied approval in 2010 because of its potential side effects.
Before making its decision Wednesday, the advisory panel reviewed two
years of data on the drug; 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was withdrawn from the market after its use was linked to high blood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, was 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 medications.
“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 impressive.”
More information
Learn more about weight loss medications at the U.S. National Institutes
of Health.
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