Consumer group Public Citizen Monday petitioned the FDA to remove Roche’s prescription version of Xenical (orlistat) from the market because of concerns of a link between the drug and colon cancer.
“This drug, which treats obesity, causes a significant increase in the incidence of aberrant cyrpt foci, which are widely believed to be a precursor of colon cancer,” the petition said.
Xenical has been on the market in the US since 1999.
GlaxoSmithKline has proposed selling an OTC version of Xenical. The FDA Friday deemed orlistat approvable as an OTC drug but that GlaxoSmithKline had to meet certain conditions before the drug could be approved.