FDA Panel Approves Orlistat (Xenical) For Over-The-Counter Sales - First Weight Loss - Diet Pill to ever be Approved by the FDA

January 23, 2006

Xenical

The weight loss drug orlistat (currently marketed as Xenical by Roche) may be available over-the-counter (OTC) soon. A Food and Drug Administration (FDA) panel of doctors and scientists voted to recommend that the regulatory agency approve orlistat for over-the-counter sales today. The FDA must still make the final approval.

The advisory panel vote was 11-2 to recommend approval. It is likely the FDA will approve the drug for OTC sales. This will be the first nonprescription weigh-loss drug approved for use in the United States by the FDA.

Xenical’s main rival is Abbott Laboratories Inc.’s Maridia. Meridia works by suppressing the appetite. Xenical is a fat-blocker but has some negative side effects. Its biggest drawbacks are excessive gas and uncontrollable bowel movements.

GlaxoSmithKline bought the rights for nonprescription Xenical from Roche Holding AG last year. Glaxo claims that by halving the dose and warning patients to eat less fat the drugs side effects could be minimized. The company also says that making the drug OTC will make it easier for more Americans to seek treatment.

It is estimated that 65 percent of Americans are either overweight or obese. Being overweight can lead to diabetes, high blood pressure and other ailments. Glaxo claims "Even modest amounts of weight loss, if achieved on a widespread basis, could have important public health benefits."

It is important to make lifestyle changes besides just taking the pills. Glaxo said "the efficacy of any weight loss therapy is inherently tied to lifestyle changes.”

The FDA panel was concerned that people may regain weight once they quit using the drug. The FDA has also expressed concerns that some consumers may not be able to tell whether nonprescription Xenical was safe for them.