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news.As part of ongoing efforts to help the growing number of obese and overweight people in the US, a Food and Drug Administration panel has voted to recommend over-the-counter sales of Xenical, a GlaxoSmithKline weight-loss pill currently available only on prescription.
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The joint non-prescription drugs advisory committee voted 11-3 in favor of a low-dose version of the drug being made available over the counter. However GlaxoSmithKline’s consumer healthcare division still needs final FDA approval before it can sell the non-prescription version.
The FDA approved the prescription version of the weight-loss drug, Roche’s Xenical, in 1999. The proposed over-the-counter version of Xenical, called Alli, would contain half the dose of the prescription capsule and would be intended for use by overweight adults only.
However, while Xenical has been found to help obese adults lose weight over a six month period, the pill’s effect is thought to end once its use is stopped. Studies have also revealed a progressive weight gain in patients after use of the drug was discontinued, and some FDA reviewers have expressed concerns that Xenical blocks the absorption of fat-soluble vitamins such as D, E, K and beta-carotene.