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(May 14, 1997 5:49 p.m. EDT)
The first anti-obesity drug that does more than merely suppress
appetite moved a
step closer to the market Wednesday. Government advisers recommended
approval of a pill that blocks the absorption of almost a third
of the fat people eat.
But scientists cautioned that Xenical ® comes with embarrassing
side effects that
worsen with the more fat that dieters eat.
And taking the pill doesn't mean people can frequent McDonald's
and still lose
weight, manufacturer Hoffman-La Roche and outside scientists agreed.
Xenical may work by causing "a kind of intestinal aversion,"
said Dr. Jules Hirsch
of Rockefeller University, before joining scientific advisers
to the Food and Drug
Administration in recommending approval of the drug. "Patients
learn there are
consequences to eating more."
Among side effects, Xenical can cause soft stools and oily
leakages as the pill
sends undigested fat out of the body so it doesn't wind up instead
on dieters'
thighs.
Xenical also can decrease absorption of vitamin D and certain
other important
nutrients, the panel warned. They unanimously recommended that
Xenical users
take carefully controlled doses of vitamin supplements.
The FDA isn't bound by advisory panel decisions but typically
follows them.
Metabolic drug chief Dr. James Bilstad said the agency would make
a decision
within a month.
Some 58 million Americans are overweight and spend $30 billion
a year fighting
the excess pounds, often futilely. Dieters have a variety of appetite
suppressants
that offer modest help.
The first new alternative in 20 years, Wyeth-Ayerst's hot-selling
Redux, alters brain
chemicals to trick the body into feeling full. A similar competitor,
Knoll
Pharmaceuticals' sibutramine, is expected to be approved within
the year.
Xenical, known chemically as orlistat, would become the first
drug to fight obesity
through the intestine instead of the brain. The drug, taken with
each meal, binds to
certain pancreatic enzymes to block digestion of 30 percent of
the fat people eat.
If Xenical is sold, no one should combine it with Redux or
other appetite
suppressants because there is no research to date showing that
would be safe,
warned Roche scientist Dr. Russell Ellison.
The FDA is evaluating how strongly to warn consumers and doctors
about that
issue, Bilstad said.
Two studies of about 1,400 patients found Xenical on top of
a mild diet -- cutting
about 600 calories a day -- helped obese people lose more weight
in a year than
people who took a dummy pill.
The weight loss was modest, scientists cautioned. On average,
Xenical patients
lost about eight more pounds than the dieters on placebo, or 5
percent to 10
percent of their initial body weight.
But when the patients went off their diets in the second year,
those who kept
taking Xenical regained only 26 percent of the weight they had
lost while placebo
dieters regained half of their weight, Roche said.
More intriguing, the FDA panel said, was that Xenical users
also saw slight drops
in their cholesterol, blood pressure and blood-sugar levels --
suggestions that the
drug might lower the risk of heart disease that strikes so many
obese Americans.
But eliminating undigested fat meant 26 percent of patients
had "oily stools" and
other gastrointestinal effects. About 20 percent of Xenical users
had enough
problems absorbing vitamins D, E and beta carotene that they were
prescribed
vitamin supplements. Vitamin D absorption is particularly worrisome,
the FDA
panel said, because it can lead to bone loss and osteoporosis,
although Roche
said studies so far don't show signs of that.
And the panel was perplexed by a handful of breast cancer cases.
Ten women
who took Xenical were diagnosed with breast cancer, while only
one breast
cancer case arose among female dieters taking a dummy pill.
Animal studies showed no evidence that Xenical caused cancer
and half of the
breast cancer was diagnosed so soon after the study began that
FDA doctors
and independent scientists said there didn't appear to be a link.
Still, the advisers
urged further study just to be safe and said Xenical should be
labeled to warn
about the puzzling finding.
"It's a little disconcerting that we're creating an illness
of malabsorption in return
for modest weight loss," said acting panel chairman Dr. Robert
Sherwin of Yale
University. But "we felt compelled to approve it" because
of the effects on
cholesterol and blood pressure.
LAURAN NEERGAARD Associated Press Writer
Copyright © 1997 Nando.net
Copyright © 1997 The Associated Press BETHESDA, Md.
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