OTC weight drug seen unsafe for some: US FDA staff

By Susan Heavey

WASHINGTON (Reuters) – A proposed over-the-counter version
of the diet drug Xenical may pose safety problems for some
patients, U.S. Food and Drug Administration staff said in
documents released on Friday.

An FDA advisory panel of outside experts is due to meet on
Monday to consider GlaxoSmithKline’s petition to sell a
half-dose version of Xenical without a prescription.

If the agency ultimately approves the drug, it would be the
only FDA-endorsed weight-loss drug available over-the-counter.
The FDA usually follows the advice of its advisory panels.

In documents released ahead of the advisory panel, FDA
staff reviewers said early data showed some diabetics and other
patients who are not supposed to take the drug did not
understand the risk after reading the label.

“Preliminary evidence suggests that nonprescription
labeling may not adequately direct the safe use of orlistat
(Xenical),” the staff wrote.

Still, the FDA reviewers said the new version helped more
patients lose weight after six months than those on placebo.

Known generically as orlistat, Xenical helps prevent fat
from being absorbed by the body but can cause excess gas and
oily discharge.

Glaxo, which bought U.S. rights for nonprescription Xenical
from Roche Holding AG last year, said the nonprescription sales
would help fight soaring obesity rates in the United States,
making it easier for overweight Americans to seek treatment.

“OTC orlistat, in conjunction with the behavioral support
program and in-pack materials, will serve as a weight loss
program,” the British drug maker said in documents also
released on Friday, adding that gastrointestinal problems could
be managed by eating less fat.

Xenical is one of two main prescription obesity drugs on
the U.S market. Its rival, Abbott Laboratories Inc’s Meridia,
suppresses appetite.

Some analysts have said side effects already keep
prescription Xenical sales low, about $460 million worldwide in
2004.

But Ira Loss, a health care analyst for Washington Analysis
Corp., said the U.S. market is ripe for an easy-to-buy,
effective weight loss drug.

About 65 percent of Americans are overweight or obese,
government data shows.

“I think every person in America who wants to lose weight
and won’t go to the doctor or pay $100 to get a prescription is
going to think about giving it a try,” said Loss. “It’s going
to be big.”

The 60-milligram dose should also curb side effects seen
with the 120-milligram prescription version, he said.

It will also cost less, Glaxo spokeswoman Malesia Dunn
said, about 60 cents per pill. Regular Xenical sells for about
$1 to $2 a pill. Both must be taken three times a day.

Despite the benefits, FDA reviewers noted people regain
weight when they stop using the drug.

They also worried that people may not be able to tell
whether non-prescription Xenical was safe for them.

Among diabetics taking medication for their condition, 35
percent correctly recognized after reading the label that they
should not take Xenical. Half of patients taking blood thinner
warfarin or cyclosporine, which prevents organ rejection,
realized they should not take the drug, the staff said.

Xenical can also lead to hepatitis, gallstones and kidney
stones. FDA staff said the cause was unclear.

Shares of Glaxo closed down 60 cents, or 1.18 percent, to
$50.15 on the New York Stock Exchange. In London, Glaxo shares
closed down less than one percent.