FDA Weighs Side Effects of Obesity Pill

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Drug regulators will decide if a prescription drug for obesity may be sold over the counter. The drug Xenical blocks the absorption of a third of the fat consumed during a meal. Its side effects concern the FDA.


The Food and Drug Administration today debates the merits of a medication for obesity. Currently the drug is only available by prescription. A special committee will discuss whether that medication should be sold over-the-counter in pharmacies. NPR's Patricia Neighmond reports.


The drug is sold under the brand name, Xenical. Generically it's known as Orlistat. It's an oral medication taken three times a day about an hour before meals. Dr. David Kelley directs obesity research at the University of Pittsburgh. He says the medication helps prevent the body from digesting some of the fat that's consumed during a meal.

Dr. DAVID E. KELLEY (Director of obesity research, University of Pittsburgh): When someone eats fat it has to be broken down in the intestines to be absorbed the same as sugars and proteins. They're all broken down into smaller units that are absorbed.

NEIGHMOND: And there's a crucial enzyme that helps the body break down that fat. Xenical inhibits the workings of that enzyme.

Dr. KELLEY: So there's a portion of the fat that is eaten that is simply not absorbed and passes on out in the bowel movement.

NEIGHMOND: So about one-third of all the fat eaten at a meal is not digested. In studies, individuals taking the medication lost about twice as much weight as those not taking it, but that's not as great as it might sound. It added up to only about 12 or 13 pounds a year. Michael Jensen is an endocrinologist at Minnesota's Mayo Clinic. He treats obese patients, many with diabetes.

Dr. MICHAEL D. JENSEN, M.D. (Professor of Medicine, Mayo Clinic College of Medicine): There are the occasional patients who do pretty darn well with it and, you know, I'd say more than the occasional patient who doesn't get much of anything or they find the side effects not worth it for the amount of weight loss that they're getting, or the cost not worth it for the amount of weight loss they're getting.

NEIGHMOND: While the side effects are not dangerous, they can be irritating, even upsetting: frequent loose stools, a sudden, urgent need to have a bowel movement, significant flatulence. Interestingly, and only anecdotally, Jensen says, the patients who seem to do best in terms of losing weight and staying on the medication are those who eat the lowest fat diets, which may mean they experience fewer of the uncomfortable side effects. The University of Pittsburgh's David Kelley.

Dr. KELLEY: The way the body works, fortunately or unfortunately, the body absorbs virtually 100% of the fat anyone eats, and Orlistat blocks the absorption of about one-third of the fat content of a meal, so if you eat a very large amount of fat intake, you know, that third becomes a larger amount of course, and that can produce some side effects of more frequent bowel movements.

NEIGHMOND: FDA experts will consider a variety of issues in their discussion of whether to allow the sale of Orlistat over the counter, including whether there should be any restrictions on who can buy the drug and how those restrictions might work.

Patricia Neighmond, NPR News.

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