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Public Citizen Xenical follow-up

This article was originally published in The Tan Sheet

Executive Summary

"Four researchers interviewed by the Cancer Letter objected to the fact that FDA advisory committee members who met on Jan. 23 to consider the over-the-counter switch of orlistat [GlaxoSmithKline's proposed OTC weight-loss drug, Alli] were not informed at or prior to the meeting about pre-cancerous changes...induced by orlistat in the colon of animals," Public Citizen states in a June 5 letter. The group submitted the letter as a supplement to its April 10 petition to ban the sale of Rx orlistat (Xenical), which also cited the link between the drug and the development of aberrant crypt foci (ACF) in rats (1"The Tan Sheet" April 17, 2006, p. 3). Although ACF may not have a causal link to polyps or colon cancer, it may be a surrogate marker for the disease. The group urges the inclusion of the animal ACF data in the agency's decision-making process on the drug and recommends that FDA remove the drug from the market...

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