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FDA approves 1st new diet drug in 13 years

By Georgiann Caruso and FOX 5 Staff

3:33 PM EDT, June 27, 2012

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SAN DIEGO -- The U.S. Food and Drug Administration Wednesday approved a new diet drug from San Diego's Arena Pharmaceuticals. It's the first diet drug approved in more than  a decade.

Belviq, or lorcaserin hydrochloride is to be combined with a reduced-calorie diet and exercise for treatment of chronic weight problems.

Specifically, the FDA said, it is approved for overweight or obese adults who have one or more medical conditions due to their weight, such as high blood pressure, type 2 diabetes or high cholesterol.

The FDA says the drug works by activating a receptor in the brain that helps a person to eat less and still feel full.

In trials, 47% of patients without type 2 diabetes lost at least 5% of their body weight. By comparison, 23% of patients treated with placebo lost at least 5% of their weight. In people with type 2 diabetes, 38% of patients on Belviq lost at least 5% of their body weight compared to 16% on placebo, according to the FDA.

"The results overall are quite modest," said Dr. Melina Jampolis, a physician nutrition specialist and CNN's diet and fitness expert. "But most experts agree that even a 5% weight loss has significant implications in terms of reducing the risk of obesity associated diseases including heart disease and diabetes."

The FDA says the manufacturer of Belviq, Arena Pharmaceuticals, will be required to conduct six postmarketing studies, including a long term cardiovascular trial to assess the risk of heart attack and stroke.

The most common side effects of Belviq in non-diabetic patients include headache, dizziness and fatigue; and in diabetic patients low blood sugar and pain, according to the FDA.