Of the hundreds of weight-loss pills and potions available for sale in the United States, none is currently approved by the FDA for over-the-counter sale as a diet treatment. But based on a January 23, 2006, press release from drug manufacturer GlaxoSmithKline, this is about to change.
On Monday, the company announced that "the U.S. Food and Drug Administration's (FDA) joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 to recommend approval of Orlistat 60 mg capsules for over-the-counter (OTC) use in the United States." One more step -- final approval from the FDA -- is necessary before the drug can be sold without a prescription.
Orlistat has been sold in prescription form as Xenical since 1999. The drug works in conjunction with a low-calorie, low-fat diet to promote weight loss. The OTC version of the drug, which Glaxo intends to sell under the trade name Alli, would be taken with meals to inhibit the body's absorption of dietary fat during digestion.
In clinical studies, participants who took a form of the proposed drug experienced embarrassing side effects when their diets contained more than the recommended upper limit of 30 percent of calories from fat. These side effects included gas, an oily discharge in undergarments, and urgent bowel movements. Some participants actually had episodes of incontinence while on the drug.
Can this be the magic bullet for weight loss we've all been waiting for? Once again the answer is no. While participants in studies did lose weight over time, many regained it once they stopped the medication. The medication does not teach behavior change and is no substitute for it. Instead of adjusting their fat intake to the recommended 30 percent of calories or less, many people who take the drug will continue to eat as usual and deal with the uncomfortable and sometimes embarrassing side effects instead of changing their eating habits.
Patients who were prescribed orlistat as a weight control medication usually received some form of education from a health professional about diet modification and behavior change. Once this product is available over the counter, consumers will not receive the same guidance and may not have or use access to a health professional who can counsel them on how best to use it.
Despite these drawbacks, with over 60 percent of Americans considered overweight, I do think there is a role for this medication. But consumers should realize that dietary and lifestyle changes must be made when taking the drug. My concern is that orlistat's wider availability in the near future will not include access to education and guidance regarding diet to ensure long-term success.