FDA Panel Recommends OTC Weight-Loss Pill
Associated Press
January 23, 2006 03:37:10 PM PST
Federal health advisers voted Monday to recommend over-the-counter
sales of a weight-loss pill now sold only with a prescription.
GlaxoSmithKline Consumer Healthcare still needs final Food and Drug
Administration approval before it can sell a nonprescription version
of orlistat, a diet pill already marketed in prescription form as
Xenical. The FDA approved the prescription version of the fat-blocking
pill made by Roche in 1999.
A joint FDA advisory committee voted 11-3 to recommend approval late
Monday following a daylong hearing. The agency usually follows the
recommendations of its outside panels of experts, but its final
decision could take months. If approved, orlistat would be the first
weight-loss drug sanctioned for over-the-counter sales.
In six-month clinical trials, obese people who took orlistat lost on
average 5.3 pounds to 6.2 pounds more than did those who were given
dummy pills. Glaxo wants people to use it for only six months at a
time, but as an over-the-counter item, its use could not be policed.
However, the pill’s effect ends once its use is stopped, said Dr.
Julie Golden, a medical officer in the FDA’s division of metabolism
and endocrinology products. A previous study showed a progressive
weight gain in patients after they discontinued use of orlistat,
Golden said.
"I think the drug is safe enough to be OTC. It’s an OTC indication.
Although there are some i’s that need to be dotted and t’s crossed,
it’s suitable for OTC use," panel chairman Dr. Alastair Wood said
following the vote.
The panel requested that the company conduct followup studies if and
when the drug does reach the market, as well as rework the pill’s
label to ensure its proper use, Wood said.
Glaxo said the drug helps the overweight slim down only when combined
with a diet and exercise regimen. The drug’s actual effect on weight
loss is "gradual and modest," said Steve Burton, Glaxo’s vice
president of weight control.
"There is no magic pill for weight loss and orlistat is not a magic
pill. Orlistat is a tool that will help people control their calorie
intake and modify their diet," said John Dent, the pharmaceutical
company’s senior vice president of research and development.
Dr. Sidney Wolfe of the watchdog group Public Citizen urged the panel
to reject the company’s application, calling it a "desperate attempt
to revive this barely effective drug by an OTC switch."
Deborah Fisher, a nurse from the Baltimore area, told the panel: "We
need this new solution to losing weight and keeping it off."
"Eat less, move more: It sounds pretty simple, doesn’t it? Well, as my
kids say, not!" said Fisher, adding that she’s dieted for 45 of her 52
years.
The proposed over-the-counter orlistat pill, called Alli (pronounced
"ally"), would contain half the dose of the prescription capsule.
Alli could cost consumers $12 to $25 a week, Glaxo said. The company
estimated 5 million to 6 million Americans a year would buy the drug
if offered over the counter. Those numbers could mean at least $1.5
billion a year in retail sales.
On Monday, FDA panel members questioned whether consumers would be
able to distinguish Alli from non-approved dietary supplements also
sold as weight-loss aids. They also expressed concern about its effect
on vitamin intake. Half of the patients enrolled in trials of the drug
failed to understand labeling directions that they should take
supplemental vitamins at least two hours before or after using the
pills.
The drug also could cause problems for organ transplant patients
taking the drug cyclosporine as well as those on warfarin, a blood
thinner. The drug’s label would warn such patients against taking the
weight-loss pill.
When taken with meals, orlistat blocks the absorption of about
one-quarter of any fat consumed. That fat — the equivalent of about
150 to 200 calories — is passed out of the body in stools, which can
be loose or oily as a result. Other side effects include gas,
incontinence and oily spotting. About half of patients in trials
experienced such side effects, the company said.
Furthermore, just 35 percent of diabetes patients in a study correctly
stated that the drug was inappropriate for them, according to FDA
documents.
Those results worried FDA reviewers, who questioned the risk of
selling the drug directly to consumers "without the principal
involvement of a learned intermediary," or prescribing doctor.
The reviewers also expressed concern about the increased potential for
abuse or misuse of a prescription-free version of the drug, especially
among bulimics or binge-eaters who could develop vitamin deficiencies
due to chronic use.
The company said there was a "very low" potential for abuse, with only
four published reports of bulimics using the drug. More than 22
million people worldwide have used orlistat in prescription form.
British-owned GlaxoSmithKline’s U.S. operations are based in
Philadelphia and Research Triangle Park, N.C.
___
On the Net: