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
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.
When taken with meals, the drug blocks the absorption
of about one-quarter of any fat consumed. That fat 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.
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, according to FDA documents.
The drug's effect on weight loss is "gradual and modest," said
Steve Burton, Glaxo's vice president of weight control.
The primary concern of FDA reviewers was the drug's potential
to create vitamin deficiencies, since its use also blocks
absorption of fat-soluble vitamins like D, E, K and beta-carotene.
The company has recommended patients take multivitamins
when using the drug.
However, at least 47 percent of people ignored that advice
in drug trials. Furthermore, just 35 percent of diabetes
patients in a study correctly stated the drug was inappropriate
for them, according to FDA documents.
Those sort of results worried FDA reviewers, who questioned
the risk of selling the drug directly to consumers "without
the principal involvement of a learned intermediary," or
The reviewers also showed 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.
British-owned GlaxoSmithKline's U.S. operations are based
in Philadelphia and Research Triangle Park, N.C.
On the Net:
Food and Drug Administration: http://www.fda.gov
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