FDA Panel Recommends Weight Loss Pill
Experts Suggest Xenical Be Sold Over the Counter
Jan. 23, 2006 -- Government advisors on Monday recommended that the FDA approve the first weight loss drug for over-the-counter sale.
The drug, known as orlistat, has been sold by prescription since 1999 under the brand name Xenical. The drug's sales have slumped in recent years.
An expert panel voted 11-3 to recommend the drug for over-the-counter sales for people who are overweight, despite concerns from several panelists that its marketer, GlaxoSmithKline, did not study its long-term use in those who are overweight.
George Quesnelle, president of the company's North American consumer health division, said that 5 to 6 million Americans are expected to purchase the drug if the FDA approves it as an over-the-counter medication. The FDA is not required to follow the advice of its advisory panels, but it often does.
The company said it plans to market the over-the-counter drug under the brand name Alli (pronounced "ally") at a dose of 60 milligrams; the drug would include extensive advice on diet and exercise.
Currently Xenical is available by prescription at a dose of 120 milligrams; it is intended for people who are obese (BMI of greater than 30) or those who are overweight (BMI greater than 27) and who have additional heart disease risk factors.
"Alli will be more than a pill. It will be a program that will help people lose weight, adopt a healthy eating program, and make other lifestyle changes," Quesnelle said following the committee's vote.
Side Effect Concerns
Orlistat works by partially blocking the absorption of fat in the intestine.
That leads to some weight loss but also causes many of orlistat's gastrointestinal side effects. Fat that isn't absorbed passes through the digestive system, causing loose stools, oily flatulence, and soiling in many patients, depending on how well users comply with a low-fat diet.
Approximately one-fifth of patients taking 120 milligrams of the drug before meals for six months experienced "oily spotting," oily stool, or abdominal pain, according to company data. Eight percent experienced uncontrolled bowel movements.
Consumers are supposed to take the weight loss pill with meals for a six-month period.
In a six-month company study, moderately overweight patients who used 60 milligrams of the weight loss drug along with diet and exercise lost an average of 4 pounds more than patients who used diet and exercise alone. Patients classified as obese (BMI greater than 30) lost an average of 5.3 pounds more than those who used placebo together with exercise and diet after six months of use.
Longer-term studies using orlistat's prescription-only form show that patients tend to gain back lost weight within two years. GlaxoSmithKline said it would launch a web site and other consumer aids to help customers maintain losses after the six months of recommended use.