Over-the-Counter Weight Loss Pill OK'd
FDA Approves Orlistat, Called "Alli," for Overweight Adults
WebMD News Archive
Feb. 7, 2007 -- The FDA approved orlistat capsules -- called "alli"
-- as an over-the-counter
weight loss aid for overweight adults.
That makes alli the first FDA-approved over-the-counter weight loss pill.
Orlistat is also sold in higher doses by prescription under the brand name
Xenical (made by Roche Laboratories).
GlaxoSmithKline, which makes alli, says the pill will be available in U.S.
stores by this summer.
Roche and GlaxoSmithKline are WebMD sponsors.
Alli doesn't excuse overweight people from cutting calories and working
"This drug is only going to be effective if it's used in conjunction
with a weight loss program -- and what that means is a reduced-fat diet,
decreased calories, and an exercise program," said the FDA's Charles
Ganley, MD, in a news conference.
"If someone just chooses to use orlistat alone -- without undertaking a
weight loss program -- then this drug is not going to be very effective,"
says Ganley, who directs the FDA's Office of Nonprescription Products.
How Much Weight Loss?
"The labeling does state that for every 5 pounds you lose from diet
alone, orlistat can help you lose 2-3 pounds more," Ganley says.
"In studies, most people lost 5-10 pounds over six months," he
"These studies were done in conjunction with a weight-loss program,"
People with a BMI (body mass index) of at least 27 may be the most likely to
benefit from alli, Ganley notes.
"If you're markedly overweight -- where your BMI is over 30, for example
-- you're likely to have more of a benefit than if it's a lower BMI,"
The FDA doesn't recommend alli for people younger than 18, but it's not
requiring buyers to show ID -- or otherwise restricting sales.
"We don't advocate that adolescents less than 18 use the product,"
He says the FDA doesn't have "major safety concerns" about alli's
use by younger adolescents.
"Our primary issue ... was that if adolescents have problems with
weight, they should be followed by a health care provider," Ganley
"Although we understand that in some instances there may be adolescents
that choose to use the product, that's not our intent. We certainly don't
encourage it," Ganley says.