The U.S. Food and Drug Administration (FDA) staff has raised a variety of warning flags in advance of an advisory committee meeting set for Jan. 23rd to consider GlaxoSmithKline’s petition to sell a half-dose version of the diet drug Xenical (orlistat) without a prescription.

The FDA staff, in documents released on Jan. 19th, questioned whether the proposed six-month treatment with the over-the-counter version of the drug would be beneficial for a “chronic” condition like obesity.

The staff’s comments were being scrutinized particularly closely by those awaiting an FDA decision on whether to approve the new prescription weight-loss drug Acomplia (rimonabant).

While the FDA reviewers did not dispute that the new version of Xenical helped more patients lose weight than those on placebo, they said “there is no evidence presented that a modest, transient weight loss due to orlistat will afford any long-term clinical benefit through either a change in behavior or a reduced risk of serious clinical diseases manifested by being overweight.

“It is difficult to define the clinical benefits of short-term treatment with orlistat,” the FDA said. “Although not studied by the sponsor, it is well known that once weight-loss treatment is stopped, lost weight is quickly regained and improvements in co-morbidities become undone.”

Patients in clinical trials of Acomplia achieved impressive weight-loss gains in the first year of taking the drug, but for the most part regained the weight in the second year if they stopped taking it.

In addition, the FDA staff expressed concern that the OTC version of Xenical, which would be marketed under the name Alli, might be taken by some type 2 diabetics (many of whom are overweight) and other patients that did not understand the risk after reading the label.

In a study cited by the reviewers, only one-third of those taking diabetes medication correctly stated that they should not use orlistat, and only half the people taking the blood-thinner warfarin correctly understood that they should not use it.

If the FDA, which generally follows the counsel of its advisory committees, ultimately approves Alli, it will be the only FDA-endorsed weight-loss drug available without a prescription.

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