Schwitzer health news blog

Going in different directions over Xenical obesity drug

At the same time that the FDA appears headed toward approving the obesity drug Xenical (orlistat) as an over-the-counter drug, the group Public Citizen has petitioned for a ban of even the prescription version of the drug.

Public Citizen today claims the drug has been known to cause a significant increase in a precursor to colon cancer. Last week, the FDA sent an “approvable” letter concerning the over-the-counter (OTC) version of orlistat to GlaxoSmithKline, which has applied to market this version. If the drug company meets certain conditions set by the FDA, the drug would probably be approved for OTC sales

“The failure to ban the prescription version of this drug or, worse, to make it much more widely available by allowing OTC sales, is a decision that is likely to increase cancer incidence,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.

“The FDA should not allow a drug … to remain on the market for the long-term treatment of a non-lethal condition when it combines so little efficacy coupled with a still unresolved potential to cause breast and colon cancer,” says the 12-page petition. “[The] FDA is now considering increasing the number of people exposed to the drug by allowing OTC use. There is no scientific justification for this decision.”