Diet pill gets OK for OTC sale

FDA approves drug without prescription

side effects an issue

February 08, 2007|By Jeremy Manier and Judith Graham | Jeremy Manier and Judith Graham,CHICAGO TRIBUNE

In a move that will expand dieters' access to a drug that has shown modest benefits and potentially embarrassing side effects, the U.S. Food and Drug Administration gave the OK yesterday for over-the-counter sales of orlistat, the first federally approved diet pill available without a prescription.

Previously released in a stronger prescription form called Xenical, the nonprescription drug will be marketed by drugmaker GlaxoSmithKline PLC, which plans to call it Alli.

Consumers hoping for a miracle weight-loss product are likely to be disappointed. Orlistat helps dieters lose weight only if it's taken in conjunction with exercise. Studies suggest the effects are moderate. On average, people who take the drug lose about six pounds more than they would have with diet alone.

The drug works by blocking the digestive system from absorbing fat. But patients benefit most if they are already on a low-fat diet. Eating too much fat increases the likelihood of what one expert described as "totally socially revolting" digestive side effects. For example, about one-quarter of patients experienced oily, spotting bowel movements while taking the drug.

Obesity experts said the drug is likely to help some people with weight problems, but only as part of a wider weight-loss plan.

"I hope people don't say this means I don't have to think about my diet," said Dr. Dan Bessesen, chief of endocrinology at the Denver Health Medical Center and associate professor of medicine at the University of Colorado Health Sciences Center.

Diet pills always have enjoyed intense consumer demand, but few have passed rigorous tests of safety and effectiveness.

In the past decade alone, the FDA has called for manufacturers to withdraw two forms of diet drugs for safety reasons. It acted to remove drugs with fenfluramine and dexfenfluramine in 1997; in 2000 it did the same with an ingredient called phenylpropanolamine, which was in Dexatrim and other drugs.

FDA officials said the approval offers an extra tool in the fight against obesity.

"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and Type 2 diabetes," said Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. "[Over-the-counter] orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."

The agency recommended that users take a multivitamin when using this drug.

The new drug would contain half the dose of Xenical prescription capsules. The price is expected to run $1 to $2 a day, company officials said. The company estimated 5 million to 6 million Americans a year would buy the drug over the counter.

Some experts said the awkward side effects might serve as a helpful deterrent to anyone tempted to see the pill as a license to indulge in bad eating.

"They'll pop a pill until they have diarrhea, and then they'll stop," said Dr. Naomi Neufeld, clinical professor of pediatrics at UCLA's David Geffen School of Medicine and a board member of the American Association of Clinical Endocrinologists.

Neufeld said she is concerned that simply making orlistat available over the counter without nutritional counseling, including visits to a dietitian, won't work.

"People who do well on this drug are educated about their diet and how to control their fat intake," Neufeld said.

Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, called the approval "the height of recklessness." Wolfe said studies have associated the prescription version of the drug with precancerous lesions of the colon. He has also called for withdrawal of the prescription version.

"The only way to lose weight and sustain that is to eat a little less and exercise more," Wolfe said.

Jeremy Manier and Judith Graham write for the Chicago Tribune.

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