The Food and Drug Administration has approved the first new prescription diet drug in 13 years: Belviq, developed by Arena Pharmaceuticals of San Diego.
Doctors say Belviq is a welcome addition to treating obesity, which is almost at 35% in the U.S., even though some call the weight-loss results modest.
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The FDA will continue to moniter studies on the drug's safety, including whether it could lead to heart attacks or strokes, after it is on the market.
The cost of the drug is not available yet..Dr. Peter Vash executive medical director of Costa Mesa-based Lindora Medical Clinics, gives us a quick look at Belviq:
Q. How does this drug work?
A. Belviq sends a message to the brain to increase serotonin levels, Â which in turn reduces appetite and triggers a sense of fullness.
Q. Who are prime candidates?
A. People who are obese with Body Mass Index (BMI) of more than 30 and overweight people who have Type II diabetes or hypertension.
Q. Who should not take this drug?Â
A. Women who are pregnant, anyone on SSRI anti-depressants (i.e. Prozac, Zoloff, etc.) or people taking migraine headache medication.
Q. Can it be used as a standalone as opposed to part of an overall weight-loss regimen?
A. Belviq has the potential to be an extremely effective and useful tool in the fight against obesity. It should only be used under the proper guidance of a physician and in conjunction with a low-calorie diet, moderate exercise and behavioral modification program. It will not have the same effect if used as a standalone.
Q. When and where will it be available?
 A. It will be available after the 1st of the year and only in licensed physician offices.
Q. What's the difference between Belviq and Fen-Phen, and how do we know there won't be similar health problems? Â
A. Fenfluramine is one half of the Fen-Phen drug, which caused the combination to be taken off the market because of its damaging effect on the heart valve. Belviq has all of the positive aspects. It decreases appetites but does not affect the heart valve. The FDA has investigated the drug in a clinical manner and in their studies have found Belviq does not have the same damaging effect. Â
Q. Are there any warning signs doctors are on the lookout for?
A. Each patient will respond differently to the drug so it is difficult to say exactly what the warning signs might be. It should always be used under the guidance of a qualified physician.Â
Some highlights from Time:
How well it works: "According to clinical trial data submitted by Arena to the FDA, nearly half of dieters without Type 2 diabetes who used the medication lost at least 5% of their starting weight â€" or an average of 12 lbs. â€" over a year, compared with 23% of those taking a placebo."
Side effects: "The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth and constipation; in patients with diabetes, side effects include low blood sugar, headache, back pain, cough and fatigue."
Health concerns: "In 2010, the FDA rejected Arena's first request for approval, asking for more evidence of its safety. New data provided by the company showed that heart problems would not occur at the low doses at which Belviq would be prescribed."
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