Diet pill OKd for sale over the counter

Diet pill OKd for sale over the counter
By Jeremy Manier and Judith Graham
Copyright © 2007, Chicago Tribune
Published February 8, 2007

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 on Wednesday gave approval to 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 non-prescription drug will be marketed by drug maker GlaxoSmithKline PLC, which plans to call the drug Alli.

Consumers hoping for a miracle weight-loss product are likely to be disappointed. Orlistat has been shown to help dieters lose weight only if it's taken in conjunction with a reduced-calorie diet. Studies suggest the effects are moderate. On average, people who take the drug lose about 6 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 thorough 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 Denver Health Medical Center and associate professor of medicine at 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 last decade alone, the FDA has called for manufacturers to withdraw two forms of diet drugs for safety reasons. The agency acted to remove drugs with fenfluramine and dexfenfluramine in 1997, and in 2000 it did the same with an ingredient called phenylpropanolamine, which was in Dexatrim and other drugs. In addition, an array of non-approved remedies tout unproven claims to help people lose weight.

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 users take a multivitamin when using this drug.

The new drug would contain half the dose of Xenical prescription capsules. The price has not been set, but it 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 potential for awkward side effects may serve as a helpful deterrent to anyone tempted to see the pill as a license to indulge in bad eating habits without consequences.

"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.

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.

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Diet pill's effects

Facts about orlistat, the diet drug that will be sold over-the-counter as Alli and is prescribed as Xenical:

- The drug must be used with a low-fat diet.

- One-quarter of pill-takers have abnormal bowel movements, including "oily" defecation.

- Orlistat works by limiting absorption of dietary fat in the gut.

- The drug eliminates 25 percent to 30 percent of the fat in the food a person eats.

Sources: GlaxoSmithKline PLC, Tribune reporting

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jmanier@tribune.com

jegraham@tribune.com