FDA OKs 1st Over-the-Counter Weight-Loss
Drug
By
Steven Reinberg
HealthDay Reporter
(HealthDay
News) -- The first non-prescription
drug to treat obesity in American adults
was approved Wednesday by the U.S. Food
and Drug Administration.
The drug, called alli (orlistat), is designed
to be used only in tandem with a reduced-calorie,
low-fat diet by overweight adults aged
18 and older. According to manufacturer
GlaxoSmithKline, the drug helps people
lose 50 percent more weight than dieting
alone, should cost consumers $12 to $25
a week, and is expected to be available
by this summer.
"This is the only FDA-approved, over-the-counter
weight-loss drug product," Dr. Charles
J. Ganley, the FDA's director of the Division
of Over-The-Counter Drug Products, said
during a teleconference. "There are
some products, primarily dietary supplements,
that make weight-loss claims and those
are not FDA-approved, although they are
permitted to make these claims."
The drug will be available in 60 milligram
capsules, to be taken three times a day
with meals that contain fat. The company
said the drug works by "blocking
about 25 percent of the fat in food a
person eats. Because of the way it works,
alli must be used in conjunction with
a reduced-calorie, low-fat diet containing
about 15 grams of fat per meal."
Eating a meal with too much fat while
taking the drug can result in bowel changes
such as loose stools, according to the
FDA. These side effects typically occur
in the first weeks of treatment, they
aren't harmful, and can be managed by
following the recommended diet of about
15 grams of fat per meal, GlaxoSmithKline
said.
It's also recommended that users take
a multivitamin once a day, at bedtime,
because the drug can interfere with the
absorption of some vitamins, GlaxoSmithKline
said.
People who have had an organ transplant
shouldn't take the drug. And anyone taking
blood-thinning medicines or being treated
for diabetes or thyroid disease should
consult a physician before using the drug,
the FDA said.
"This drug is only going to be effective
if it's used along with a weight-loss
program," Ganley said. "That
means a reduced-fat diet, decreased calories
and an exercise program."
"If someone uses the drug without
a weight-loss program, it's not going
to be very effective," he added.
A higher dose of orlistat (120 milligram
capsules) has been marketed as the prescription
drug Xenical in the United States since
1999.
While the company claims Xenical's safety
has been demonstrated by nine years of
worldwide use in 146 countries, the consumer-advocacy
group Public Citizen last year petitioned
the FDA to remove Xenical from the U.S.
market.
Public Citizen contended that the higher-dose
drug might increase the risk of aberrant
crypt foci, which are widely believed
to be precursors to colon cancer.
Late Wednesday, the advocacy group issued
a statement criticizing the FDA's approval
of the over-the-counter version of the
drug.
"At a time when colon cancer is a
leading cause of death and disease in
the United States, the Food and Drug Administration's
decision to approve, for over-the-counter
use, a diet drug that clearly causes precancerous
lesions of the colon is the height of
recklessness and shows a profound lack
of concern for the public's health,"
Dr. Sidney M. Wolfe, director of Public
Citizen's Health Research Group, said
in the statement.
One obesity expert isn't sure the new
OTC drug will be effective for most people.
"The drug is probably safe,"
said Dr. Raj Padwal, an assistant professor
of general internal medicine at the University
of Alberta. "However, I'm not sure
the half-strength dosage will have much
effect."
Full-strength dosage reduces weight by
less than 3 kilograms (6.6 pounds), on
average, Padwal said.
"People may only lose 1 to 2 kilograms
(2.2 to 4.4 pounds) on this half-strength
dose. Whether that is worthwhile is questionable.
The occasional patient may benefit, but
many patients may not. For those patients
who need extra incentive to adhere to
a low-fat diet, the drug may help,"
Padwal said.
Padwal and a colleague recently published
an article in The Lancet that noted precious
little evidence exists that proves weight-loss
drugs such as orlistat actually reduce
the risks of heart attack, stroke and
diabetes associated with being overweight
or obese.
The FDA's approval of the first over-the-counter
drug for weight loss comes as the United
States and other western nations are struggling
with an unprecedented obesity epidemic.
According to the U.S. National Center
for Health Statistics, 30 percent of American
adults 20 years of age and older -- more
than 60 million people -- are obese. And
another 36 percent are considered overweight.
Overall, this drug is likely to be limited
in the direct harm it causes, but also
in the good it does, said Dr. David L.
Katz, an associate professor of public
health and director of the Prevention
Research Center at Yale University School
of Medicine.
"It is a relatively ineffective weight-loss
aid," he said. "If availability
of the drug distracts people from the
tried-and-true approach to weight control,
eating well and being active, then the
FDA decision could prove more harmful
than helpful, in spite of good intentions."