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.

The researchers found: "Among 65 estimates of association calculated across 20 different cohorts for 11 different types of cancer and 6 different ways to assess omega-3 fatty acid consumption, only 10 are statistically significant. Significant associations between omega-3 fatty acid consumption and cancer risk were reported for breast cancer in 4 studies; for colorectal cancer in 1; for lung cancer in 2; for prostate cancer in 2; and for skin cancer in 1. However, for each breast, lung, and prostate cancer, there were significant associations for both increased risk and decreased risk and far more estimates that did not demonstrate any association. The study that assessed skin cancer risk found a significantly increased risk. Hence, no trend was found across many different cohorts and many different categories of omega-3 fatty acid consumption to suggest that omega-3 fatty acids reduce overall cancer risk."

"Omega-3 fatty acids appear not to affect a mechanism of cancer development that is common across the different types of cancers evaluated in this report. Likewise, there is little to suggest that omega-3 fatty acids reduce the risk of any single type of cancer," they write.

"A large body of literature spanning numerous cohorts from many countries and with different demographic characteristics did not provide evidence to suggest a significant association between omega-3 fatty acids and cancer incidence. Dietary supplementation with omega-3 fatty acids is unlikely to reduce the risk of cancer," the researchers conclude.

jama.ama-assn/

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