The first over-the-counter weight-loss pill won approval from U.S. health officials on Wednesday, giving the two-thirds of Americans who are obese or overweight another option to help them shed pounds.
GlaxoSmithKline's pill Alli reduces the amount of fat the body absorbs from food. The drug is a half-dose version of a prescription medicine called Xenical, sold by Roche AG.
The FDA cleared Alli for use by overweight adults and stressed the drug should be combined with a reduced-calorie, low-fat diet and exercise.
"This drug is only going to be effective if used in conjunction with a weight-loss program," Dr. Charles Ganley, FDA's head of nonprescription drug products, told reporters.
The drug's packaging will say that for every 5 pounds lost through diet, Alli can help a person drop 2 or 3 pounds more.
About 28 percent of Alli users in company studies lost 5 percent to 10 percent of their body weight over six months, compared to about 18 percent who took a placebo, Ganley said.
Alli can be taken up to three times a day with meals. It works by reducing the amount of the fat that the body absorbs by about 25 percent. The undigested fat is eliminated through bowel movements, which can cause side effects such as gas and oily discharge.
Eating a low-fat diet can reduce the side effects, Glaxo and the FDA said. Alli users should take a multivitamin at bedtime to make up for the possible loss of certain nutrients, the FDA added.
Alli is the only non-prescription weight-loss remedy with FDA approval. Many companies sell over-the-counter supplements that claim weight-loss benefits, but those products are not cleared by the FDA.
Consumer group Public Citizen, which has urged a ban on prescription Xenical, said Alli should not have been approved because of precancerous colon lesions seen in animal studies.
Glaxo officials said those concerns were not valid.
Public Citizen also called the drug's benefits "marginal."
Alli will cost about $2 a day and be in stores by summer.
The company will provide consumers information about exercise and healthy meals, plus online tools to help them stick to a weight-loss regimen, officials said. Glaxo will sell a book about Alli and weight loss before the drug hits stores, Burton said.
"We want to emphasize that Alli is not for everyone. It is for that person who is committed to making those dietary changes," Burton said.
People who have had an organ transplant should not take Alli because of possible drug interactions, the FDA said. Patients taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a doctor before taking it, the agency added.
Xenical will continue to be sold by prescription. Abbott Laboratories also sells a prescription diet drug called Meridia. Sanofi-Aventis is seeking approval for another prescription weight-loss pill, Acomplia.
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