FDA approves long-term weight loss drug Belviq - WSFA.com: News Weather and Sports for Montgomery, AL.

(RNN) – The Food and Drug Administration approved the prescription weight-loss drug Belviq for obese and overweight people, likely as an answer to an epidemic that affects more than one-third of people in the U.S.

The drug manufactured by Arena Pharmaceuticals GmbH of Zofingen, Switzerland was approved for people who had a body mass index (BMI) of 30 or higher, considered obese, or who are overweight (27 BMI) with at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol.

Belviq is not a miracle drug, however. The FDA advises it is meant to be used "as an addition to a reduced-calorie diet and exercise, for chronic weight management."

Tests conducted for one year showed the average loss of body weight was between 3 and 3.7 percent.

"Obesity threatens the overall well being of patients and is a major public health concern," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a release. "The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition."

It used to be popular to say that "an apple a day keeps the doctor away." However, anyone who actually lived by that motto is probably long gone by now.

Less than one-fifth of adults eat at least two serving of fruit and three servings of vegetables each day, and that figure decreases by half in adolescents.

The Centers for Disease Control and Prevention released a projection in May that said 40 percent of Americans, about 110 million people, will be obese by 2030.

Healthcare spending on diseases related to obesity has jumped from an estimated $147 billion in 2008 to almost $200 billion currently, almost one quarter of overall health costs.

Belviq works by activating a serotonin receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food.

Drugs that the FDA found to cause stimulation of a separate serotonin receptor were pulled off the shelves 15 years ago.

In 1997, the weight-loss drugs fenfluramine and dexfenfluramine (fen-phen) were withdrawn from the market after evidence emerged that they caused heart valve damage, an effect linked to activation of the serotonin 2B receptor on heart tissue. American Home Products Corp. (now Wyeth) manufactured fen-phen under the names Pondimin and Redux.

The FDA said it never officially asked American Home Products to pull the third drug related to the fen-phen mixture, phentermine, commonly used as a stimulant in combination with the other two.

The findings led to numerous class action lawsuits, and doctors were still diagnosing patients with adverse side effects of the drugs years after they disappeared from shelves.

The FDA said Belviq does not appear to activate the same receptor when used at the approved dose of 10 milligrams twice a day.

The most serious side effects for the drug include a potentially life-threatening reaction that causes the body to have too much serotonin and disturbances in attention or memory, according to the FDA.

The FDA will require Belviq's manufacturer to conduct postmarketing studies to determine long-term cardiovascular effects.

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