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The public's quest for an elusive magic pill for weight loss got easier in February thanks to federal regulators, but critics say the medication should stay behind the pharmacy counter, if not out of the hands of consumers entirely. The Food and Drug Administration (FDA) approved GlaxoSmithKline's (GSK) Alli (orlistat) as the first overthe-counter (OTC) weight loss drug, offering millions help in fending off obesity. The FDA's approval limits use of the drug to adults over age 18 and requires it be accompanied by an exercise program and a reduced-calorie, low-fat diet.
Originally approved in 1999 as Xenical (Roche), the nonprescription drug will be manufactured by GSK and should appear on store shelves this summer in the form of 60 mg capsules, which is half the prescription formulation, according to the company's Web site. GSK recommends the use of Alli as part of a behavioral weight loss program. GSK must state on the packaging that for every five pounds lost through dieting, the drug can help a person lose an additional two to three pounds.
The most common side effects of orlistat include a change in bowel habits, which may include loose stools, says the FDA. But the FDA also notes that consumers can reduce the likelihood of this side effect occuring by eating a lowfat diet. According to the FDA, Alli is not recommended for patients who have had an organ transplant; the FDA also advises consumers taking anticoagulants or patients with diabetes or thyroid disease to consult with their physicians before using orlistat.
"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes. OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," says Douglas Throckmorton, MD, deputy director of FDA's Center for Drug Evaluation and Research.
Debate over the drug's safety began a year ago, when Public Citizen, a Washington, D.C.-based advocacy group, opposed OTC approval of orlistat due to "marginal benefits, common gastrointestinal adverse reactions, significant absorption inhibition of vitamins A, D, K, and E, and problematic use in millions of people who use the anticoagulant warfarin," notes Sidney M. Wolfe, director of the health research group. Public Citizen previously urged the FDA to ban prescription use of Xenical.
"At a time when colon cancer is a leading cause of death and disease in the U.S., the FDA's decision to approve OTC [sale] of a drug that clearly causes precancerous lesions of the colon is the height of recklessness and shows a profound lack of concern for the public's health," adds Wolfe.
ALLI IS NOT FOR EVERYONE
GSK touts the OTC drug as a clinically proven alternative to quick-fix supplements that mislead overweight adults away from strategies backed by medical science. Consumers who purchase Alli will receive a companion guide, a guide to healthy eating, a daily journal, a calorie and fat counter, quick-fact cards, and access to an online action plan at a company-sponsored Web site.
"I applaud the Alli program for stressing the importance of a
reduced-calorie, low-fat diet in conjunction with a weight-loss medicine
proven to be safe and effective. This lines up with research that shows even
modest, gradual weight loss provides significant health benefits," notes
Caroline Apovian, MD, director of the Center for Nutrition and Weight
Management at Boston Medical Center. 
Footnotes
To see how GlaxoSmithKline is educating consumers about orlistat, access the medication's Web site at www.myalli.com.
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