Dr. Sidney M. Wolfe, Director of Public Citizen’s Health Research Group, a national, nonprofit consumer advocacy organization based in Washington, D.C., said the drug clearly causes pre-can­cerous lesions of the colon (aberrant crypt foci or ACF) and its approval for over-the-counter availability is, “the height of recklessness and shows a profound lack of concern for the public’s health.”

The connection of ACF with carcinogenesis is so well-recognized that the appearance of ACF in rats is used by many groups to test the potential carcinogenicity of chemicals, Wolfe said. For example, the Environmental Protection Agency (EPA) uses an ACF assay in its tests of possible carcinogens.

In April 2006, after opposing the OTC switch, Public Citizen petitioned the FDA to ban the pre­scription version of orlistat – Xenical – because of the two studies documenting its ability to cause ACF. There are no human studies of long enough duration or follow-up to make any acceptable statement allaying concerns about human cancer from orlistat.

In opposing the over-the-counter approval a year ago, the Public Citizen said, that “the switch of orlistat to OTC status would be a serious, dangerous mistake in light of its marginal benefits, frequent co-existence of other diseases, common, bothersome (gastrointestinal) adverse reactions, significant inhibition of absorption of fat soluble vitamins (A, D, K and E), and problematic use in the millions of people using the blood thinner warfarin (Coumadin^®) because of orlistat-induced Vitamin K deficiency.”

OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli ^Tm and is indicated for use in adults ages 18 years and older along with a reduced-calorie, low-fat diet, and exercise program, the FDA said.

“We strongly urge people not to use this potentially dangerous drug,” Wolfe said, “and we pre­dict that, like the rapidly declining sales of the prescription version, the over-the-counter version will turn out to be a loser after enough people have a bad experience with it.

SOURCES: http://www.fda.govibbs/topics/NEWS/2007/NEW01557.html http://www.citizen.org/hot_issues/issue.cfmM=1539