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Home » Lose Weight » FDA OKs first new weight-loss drug in years

by Rob Stein, National Public Radio

June 27, 2012

For the first time in 13 years, the Food and Drug Administration has approved a new drug to help people lose weight.

The FDA gave the green light to Arena Pharmaceuticals to sell Belviq, or lorcaserin generically, a twice-a-day pill that suppresses appetite and appears to affect metabolism by influencing levels of the brain chemical serotonin.

"Obesity threatens the overall well being of patients and is a major public health concern," Janet Woodcock, director of the FDA's drug center, said in a statement. "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."

The drug was approved for obese people (those with a body mass index of 30 or more) and overweight people with a BMI of 27 or more, who also have at least one weight-related health condition, such as high blood pressure, Type 2 diabetes or high cholesterol.

In studies sponsored by Arena, about half of patients taking Belviq lost about 5 percent of their body weight after a year. The most common side effects include headache, dizziness, fatigue, nausea, dry mouth, and constipation.

The FDA had rejected the drug in 2010 after a panel of experts advised the agency to give it a thumbs down because of safety concerns. Early studies indicated the drug might cause tumors in rats and possibly heart problems in people. Lorcaserin works in a way one part of the fen-phen diet pill combination that was pulled from the market in 1997 because it caused heart valve damage.

But agency the company submitted new data aimed at alleviating those concerns and the same panel endorsed approval in May. Some panel members, however, again expressed concerns about the drug's safety, especially the heart problems, as have some consumer advocates.

"Faced with this serious concern, it would be dangerous and unconscionable for you to allow the FDA to disregard the available evidence and subject large numbers of obese patients, already at risk for cardiovascular disease, to the added risk of damaged heart valves," wrote Sidney M. Wolfe of the Public Citizen's Health Research Group, in a letter to FDA Commissioner Margaret A. Hamburg.

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FDA OKs first new weight-loss drug in years

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Home » Lose Weight » FDA OKs first new weight-loss drug in years