The consumer group, Public Citizen, said that the obesity treatment can cause a significant increase in aberrant crypt foci (ACF) – widely believed to be a precursor to colon cancer.
Recently, GlaxoSmithKline, which has the rights to sell over-the-counter (OTC)Xenical, received a letter from the FDA indicating that the drug may be approvable for non-prescription sales.
Public Citizen’s petition is based on findings from the pharmacology review of Roche’s own data and a recent independent confirmation that Xenical causes ACF in the colon of rats.
“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.