FDA Panel Gives Blessing to New Weight-Loss Drug

THURSDAY, May 10 (HealthDay News) — An advisory panel to the
U.S. Food and Drug Administration on Thursday recommended approval of the
weight-loss medication lorcaserin, even though concerns remain about
cardiovascular side effects.

If the agency were to give the nod to the drug, lorcaserin would become
the first new weight-loss pill made available to Americans in a decade.
The FDA is not bound to follow the advice of its expert panels, but it
typically does.

The panel of experts voted 18 to 4, with one abstention, for approval,
saying the drug’s benefits “outweigh the potential risks when used long
term” for people battling excess weight, the Associated Press,
reported.

Lorcaserin has not always received such a favorable reception.
According to the AP, in 2010 scientists voiced concern that the
drug might come with health risks, citing tumors that had developed in
animal testing involving the drug.

However, Arena Pharmaceuticals, the San Francisco-based company that
makes lorcaserin, has since submitted additional data in hopes the FDA
might look more favorably on the drug.

According to a review of the available research posted by FDA staff
online on Tuesday, that new data suggests that lorcaserin carries only a
“negligible risk” of cancer in humans, the AP said. But concerns
over the potential for cardiovascular risks — hypertension in people with
diabetes, for example, or injury to heart valves — remain.

According to the AP, lorcaserin is one of three experimental
weight-loss drugs that the FDA is taking a second look at after first
saying no to the medications in 2010 or early 2011 because of concerns
about significant side effects.

In February, another new weight-loss drug, Qnexa, was endorsed by an
FDA advisory panel. The agency is expected to make a final decision on
Qnexa in July.

More information

Find out more about healthy weight loss at the U.S. Centers for Disease Control and Prevention.

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