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FDA Approval of Over-the-Counter Orlistat Is Reckless

Feb. 7, 2007

FDA Approval of Over-the-Counter Orlistat Is Reckless

Statement of Dr. Sidney M. Wolfe, Director of Public Citizen’s Health Research Group

At a time when colon cancer is a leading cause of death and disease in the United States, the Food and Drug Administration’s (FDA) decision to approve, for over-the-counter (OTC) use, a drug that clearly causes pre-cancerous lesions of the colon (aberrant crypt foci or ACF*) is the height of recklessness and shows a profound lack of concern for the public’s health. This marks the first time, to my knowledge, that the FDA has approved a drug for over-the-counter use despite knowing in advance that the drug causes either cancer or pre-cancerous lesions. This decision raises very serious questions about the competence of former National Cancer Institute Director Dr. Andrew von Eschenbach in allowing the approval of a drug that may well increase the incidence of colon cancer in this country.

Emphasizing that this risk is not accompanied by any documented benefit, the label of the prescription version, Orlistat, has been required to state that “The long-term effects of orlistat on morbidity or mortality associated with obesity have not been established.”

In opposing the over-the-counter approval a year ago, we stated 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)” (the latter because of orlistat-induced Vitamin K deficiency).

We strongly urge people not to use this potentially dangerous drug, 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.

*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. 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, we 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.


Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C.