FDA panel backs easing sale of diet pill
Xenical may become 1st such treatment sold over the counter
WASHINGTON -- GlaxoSmithKline PLC won the support of a US advisory panel to sell its Xenical diet pill without a doctor's prescription.
The Food and Drug Administration advisers voted 11 to 3 in favor of allowing over-the-counter access to Xenical, known chemically as orlistat, for use by overweight adults for up to six months.
The FDA usually follows the recommendations of its advisory panels, without an obligation to do so.
If the agency ultimately approves the drug, it would be the first prescription weight-loss drug to be approved for sale over the counter at a time when two-thirds of Americans are overweight or obese.
The advisers overcame FDA staff concerns that patients might misuse the drug, which has been available by prescription in the United States since 1999. Orlistat would be the first weight-loss medication approved for sale without the supervision of a doctor. Moderately overweight patients who took 60 milligrams of orlistat in a four-month study had an average weight-loss of 1.1 kilograms, or 2.4 pounds.
''It's a small amount of weight, it's a short-term usage," said panelist Melanie Coffin, who served as a representative of patients, during the meeting yesterday in Bethesda, Md. ''It's one more tool to help folks."
London-based Glaxo would market the nonprescription version under the brand name Alli at half of its current 120-milligram dosage. The company is targeting some of the 65 percent of Americans who are overweight, based on federal statistics. Xenical generated $497 million of worldwide sales in 2004.
While about half of participants in focus groups experienced gastrointestinal side effects from orlistat, only 9 percent of participants discontinued use of the drug, Glaxo told the FDA panel. The company said it would add warnings on its packaging and educate pharmacists and transplant centers about risks for certain patients.
''There is no magic pill for weight loss, and orlistat is definitely not a magic pill," John Dent, Glaxo's vice president of research and development, told the panel. ''Orlistat is a tool that will help people control their calorie intake."
Panel member Thomas Carpenter said additional levels of oversight by pharmacists or others would be needed to spot ''red flags" in patients who may experience complications from using the drug without a doctor's prescription for a longer period of time than recommended.
Panelists also raised concerns that patients may lose the ability to absorb critical vitamins while taking orlistat or regain the weight they have lost after treatment is stopped. Glaxo has proposed that patients take one or two of the over-the-counter tablets three times a day for up to six months.
Xenical works by blocking about one-third of the fat in food from being digested. The drug also can reduce the absorption of some fat-soluble vitamins and has been linked to kidney stones, gallstone, hepatitis and, perhaps, pancreatitis, FDA staff said in a report on the agency's website last week.
''The challenge here is to somehow make a reasonable risk-benefit assessment of a drug that, if available over the counter, will be used by at least some people for cosmetic weight loss," said Eric Coleman, medical team leader for the FDA's division of metabolism and endocrinology products.
The FDA staff, in a report the agency posted Friday on its website in preparation for the panel meeting, expressed concern that diabetics, transplant patients and people taking blood- thinners may not use an over-the-counter version of the weight-loss drug correctly.