Non-Prescription Diet Pill Gets FDA Approval

February 8, 2007

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February 8, 2007

The FDA has approved a non-prescription diet pill that blocks some fat absorption in the body. But critics say the pill hasn't been adequately tested and worry about some of its side effects.

RENEE MONTAGNE, host:

This is MORNING EDITION from NPR News. I'm Renee Montagne. Good morning.

STEVE INSKEEP, host:

I'm Steve Inskeep.

Today in Your Health, the Food and Drug Administration has approved the first diet pill to be sold without prescription in pharmacies.

NPR's Patty Neighmond has this report on the drug known by its generic name, Orlistat.

PATTY NEIGHMOND: Orlistat works by blocking intestinal absorption of fat. Until now, it's been available only by prescription. You'll be able to get it soon over the counter in a drugstore. Dr. Charles Ganley is FDA director of non-prescription products.

Dr. CHARLES GANLEY (FDA): This drug is only going to be effective if it's used in conjunction with the weight-loss program. And what that means is a reduced fat diet, decrease calories, and an exercise program.

NEIGHMOND: The new medication is sold by GlaxoSmithKline. It will be called Alli. It's only half the concentration of the original prescription version. Company officials say their studies showed that for every five pounds people lost by diet alone, they lost another two to three pounds with the help of the drug.

But what you eat and how much is still important. If people don't stick to a low-fat diet while they're taking the pill, they'll have more side effects, mostly because of the way the drug works. Company spokesperson and pharmacist Dubue Benzal(ph).

Ms. DUBUE BENZAL (Spokesperson, GlaxoSmithKline): It's working by preventing 25 percent of the fat you're eating from being absorbed. So if you're eating a lot of fat, then you're obviously going to be excreting a lot of fat.

NEIGHMOND: Patients report diarrhea, increased gas and a sudden urgent need to go to the bathroom. Some patients just can't tolerate it.

Dr. Karen Young is a pediatrician with the Arkansas Children's Hospital. She's prescribed the drug for severely overweight teens. In her experience, some of them just stop taking it.

Dr. KAREN YOUNG (Arkansas Children's Hospital): They were young people who really had high fat diets and I warned them that they really needed to cut the fat in their diet, and that the medicine was not magic, and told them that they would have a bad side effects if they did eat a lot of fat.

NEIGHMOND: The prescription version of Orlistat was not widely used because most insurance companies and Medicaid did not pay for it. The new version will cost about $2 a day. It's expected to have fewer side effects because the dose is lower. Young says that for people who just haven't been able to lose weight, the ease of buying it over the counter in a drugstore could provide a jumpstart.

Dr. YOUNG: If they can lose some weight and they really are serious about making the healthy lifestyle changes, and they really work hard at it, then they may very well be successful.

NEIGHMOND: The drug is approved for individuals over 18. The FDA has not instructed pharmacies to put the drug behind the counter, which means it will likely appear on regular product shelves available to anyone who walks by. And skeptics point out the studies had only looked at Orlistat for four years. That's not enough, says the consumer advocacy group Public Citizen. Public Citizen says some studies have raised concerns about health hazards over the long term.

Patty Neighmond, NPR News.

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