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LINDA WERTHEIMER, HOST:

This is MORNING EDITION, from NPR News. I'm Linda Wertheimer.

RENEE MONTAGNE, HOST:

And I'm Renee Montagne. The Food and Drug Administration has approved the first new weight-loss drug in 13 years. That decision comes after a series of disappointments in the hunt for new ways to help seriously overweight people lose that weight. NPR's Rob Stein reports.

ROB STEIN, BYLINE: The new drug is called Belviq. It works by triggering a switch in the brain that ends up suppressing appetite. Abraham Thomas. at the Henry Ford Hospital in Detroit, led a panel of experts that reviewed the drug's safety and effectiveness for the FDA.

DR, ABRAHAM THOMAS: On average, in most patients, it caused about 5 to 8 percent of weight loss. Some patients lost more than 10 percent.

STEIN: Based on that, the FDA approved Belviq for two types of patients - people who are obese, meaning they have a body mass index of at least 30; and people who are just very overweight but also have at least one health problem, like high blood pressure, high cholesterol or Type 2 diabetes. James Zervios is with the Obesity Action Coalition, which has been pushing for new weight-loss drugs.

JAMES ZERVIOS: There's 72 million adults affected by obesity. Now, they have something to look at, to combat this disease.

STEIN: With the obesity epidemic raging out of control, there haven't been many options. The last weight-loss drug the FDA approved, in 1999, doesn't work very well, and it has side effects. Diets and exercise only help a little. Surgery works, but it's pretty much a last-ditch option. Scott Kahan is at the George Washington University.

DR. SCOTT KAHAN: Of course, healthy eating and physical activity, is an important strategy. But on its own, that's not enough. We've been trying that for decades, and obesity rates have only increased.

STEIN: But not everyone is pleased by the FDA's decision. The big worry is safety. The FDA had rejected Belviq once before, because of safety concerns. The main worry is that it might damage people's hearts. Sidney Wolfe is with the Public Citizen Health Research Group, a consumer advocacy group.

DR. SIDNEY WOLFE: Some doctors who are treating people who are overweight - and unfortunately, the FDA - are so desperate that they seem to be throwing caution to the winds.

STEIN: Wolfe pointed out that earlier weight loss drugs, like fen-pfen and Meridia, were both pulled off the market for causing heart problems. And Belviq is similar to fen-pfen in some ways.

WOLFE: The history of diet drugs in this country is a grim history; of one after another coming on the market, and then having to be taken off the market after the damage that they cause was suspected.

STEIN: But the FDA concluded that the benefits of the drug outweighed the risks, which so far seem generally minor. Proponents argue that the FDA's decision marks an important shift when it comes to weight-loss drugs. They're not just diet pills that people take for cosmetic reasons. They're needed to treat a serious disease. So like drugs for heart disease and cancer, some risks might be acceptable. James Zervios again, with the Obesity Action Coalition.

ZERVIOS: This is a serious epidemic, and we have to do something about it. And I think that message is finally beginning to penetrate. This is about health. This is not a cosmetic issue.

STEIN: Abraham Thomas, who headed the FDA panel, agrees.

THOMAS: There's no medication that is 100 percent safe. And what we're trying to do is balance the risks of the medication versus the benefits of treating obesity.

STEIN: The FDA is requiring the company that makes Belviq to conduct six additional studies, to see if the benefits for treating obesity do, indeed, outweigh any risks.

Rob Stein, NPR News.

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