FDA panel gives weight-loss drug the thumbs up

Jan 24 2006

An FDA advisory panel has declared that an over-the-counter weight-loss drug appears to be safe and effective for a six month period of use.

GlaxoSmithKline's weight-loss drug Alli is said to be a a low-dose version of the prescription drug Xenical (Orlistat).

The panel reached a unanimous decision that the proposed over-the-counter version would help patients lose weight after six months of therapy.

They agreed that the drug appeared to be in general safe to use, but some members voiced concerns regarding repeated and long-term use.

One panelist Dr. Neal Benowitz, a professor at the University of California in San Francisco, said as yet no long-term effectiveness had been shown.

Although the FDA will consider the panel's advice before making its final decision, as a rule the organisation accepts the rulings of it's advisory panels.

If the drug is approved it will be the first U.S.-endorsed weight-loss drug to be sold over the counter and comes at a time when two-thirds of Americans are estimated to be overweight or obese.

The over-the-counter version will be half the dosage of it's original 120-milligram prescription counterpart; both work by preventing some fats from being absorbed by the body.

Side effects experienced by 50% of those who tried the prescription drug Xenical, included oily stools, spotting and excess gas.

According to Glaxo the half-dose version will reduce those side effects.

Glaxo recommends the drug be used along with other lifestyle changes such as a low-fat diet for maximum benefit.

John Dent, senior vice president for research and development, says Xenical is not a magic pill for weight loss, but rather a tool that will help people control their calorie intake and modify their diet.

Many health groups and doctors have urged easier access to such drugs and agree that many need help in making lifestyle changes.

The unpleasant side effects are thought to have helped retard the sales of Xenical.