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Alli over-the-counter weight loss pill wins approval
Washington: Thu, 8 Feb 2007     

The first over-the-counter weight-loss pill has won approval from
US health officials, giving the two-thirds of Americans who are
obese or overweight another option to help them shed pounds.

GlaxoSmithKline Plc's pill Alli reduces the amount of fat the body
absorbs from food. The drug is a half-dose version of a
prescription medicine called Xenical, sold by Roche AG.

The Food and Drug Administration cleared Alli for use by
overweight adults and stressed the drug should be combined with
a reduced-calorie, low-fat diet and exercise.

'This drug is only going to be effective if used in conjunction with
a weight-loss program,' Dr Charles Ganley, FDA's head of
nonprescription drug products, told reporters.

The drug's packaging will say that for every 5 pounds lost
through diet, Alli can help a person drop 2 or 3 pounds more.

About 28 per cent of Alli users in company studies lost 5 per cent
to 10 per cent of their body weight over six months, compared to
about 18 per cent who took a placebo, Ganley said.

Alli can be taken up to three times a day with meals. It works by
reducing the amount of the fat that the body absorbs by about 25
percent. The undigested fat is eliminated through bowel
movements, which can cause side effects such as gas and oily
discharge.

Eating a low-fat diet can reduce the side effects, Glaxo and the
FDA said. Alli users should take a multivitamin at bedtime to
make up for the possible loss of certain nutrients, the FDA added.

Alli is the only non-prescription weight-loss remedy with FDA
approval. Many companies sell over-the-counter supplements
that claim weight-loss benefits, but those products are not
cleared by the FDA.

Consumer group Public Citizen, which has urged a ban on
prescription Xenical, said Alli should not have been approved
because of precancerous colon lesions seen in animal studies.

Glaxo officials said those concerns were not valid.

Public Citizen also called the drug's benefits 'marginal.'

Alli will cost about $2 a day and be in stores by summer, Steven
Burton, vice president for GlaxoSmithKline Consumer
Healthcare's weight control division, said in an interview.

Glaxo previously estimated that 5 million to 6 million Americans
would buy Alli over the counter. Burton said the potential market
was likely larger, but declined to give sales projections.-Reuters

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