Federal approval of an over-the-counter version of orlistat weight-loss capsules drew rave press notices this week despite critics who say the drug causes pre-cancerous lesions of the colon.

Public Citizen's Dr. Sidney Wolfe called the Food and Drug Administration's action "the height of recklessness" and said "shows a profound lack of concern for the public's health."

"At a time when colon cancer is a leading cause of death and disease in the United States, the Food and Drug 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," Wolfe said.

"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."

ConsumerAffairs.com's health advisor, Henry Fishman, M.D., also counseled caution.

"Alli can help you shed a few pounds, if you cut back on calories and exercise regularly. It is not a magic bullet by itself," Fishman said. "It can cause digestive problems and is not for everyone, especially if you have a chronic health problem. So, talk to your doctor before taking it."

Orlistat was initially approved in 1999 as a prescription drug to treat obesity, and remains a prescription drug for obesity at a higher dose than the OTC version.

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

Wolfe noted that the prescription version of the drug has long noted on its label that the cancer risk is not accompanied by any documented benefit, with the statement 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, Wolfe 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)" (the latter because of orlistat-induced Vitamin K deficiency).

The FDA was hardly effusive in its announcement.

"OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," said Dr. Douglas Throckmorton, Deputy Director for FDA's Center for Drug Evaluation and Research.

Orlistat decreases the intestinal absorption of fat. Because of the possible loss of certain nutrients, it is recommended that people using orlistat should also take a multivitamin at bedtime, the FDA said.

The most common side effect of the product is a change in bowel habits, which may include loose stools. Eating a low fat diet will reduce the likelihood of this side effect. Also, people who have had an organ transplant should not take OTC orlistat because of possible drug interactions.

In addition, anyone taking blood thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat.

Wolfe predicted the drug would be a "loser."

"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," he said.

"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, we petitioned the FDA to ban the prescription version of orlistat, Xenical, because of the two studies documenting its ability to cause ACF."

He said there are no human studies of long enough duration or follow-up to make any acceptable statement allaying concerns about human cancer from orlistat.