Roche Holding AG's prescription diet drug Xenical should immediately be pulled from the U.S. market after recent data linked it to precancerous colon lesions in animal studies, a consumer group told federal health regulators on Monday according to Reuters. Public Citizen, in a petition, also asked the U.S. Food and Drug Administration to reject making the weight-loss pill widely available over the counter. On Friday, the FDA said it granted GlaxoSmithKline Plc conditional approval to sell the drug without a prescription if it first meets certain undisclosed criteria. Glaxo owns U.S. rights for nonprescription sales of Xenical. "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," Public Citizen wrote. The group said a December 2005 study confirmed earlier company data showing Xenical, known generically as orlistat, can cause abnormal cell growth in the lining of the colon. Experts widely recognize the lesions as an early indicator of cancer, the advocacy group added. The study, published in the journal Cancer Letters, found "a significant increase" of colon lesions in rats given Xenical regardless of whether they were on high-fat or standard diets. "This finding makes it even clearer how ill-advised switching orlistat to OTC status would be," the petition said. Representatives for the two drug makers were not immediately available to comment on the petition. Xenical comes in 120-milligram capsules to be taken three times a day with meals. The proposed nonprescription version, called Alli, comes in 60 milligram tablets with one to two taken with meals. It works by preventing fat from being absorbed by the body but can cause excess gas, oily discharge and other gastrointestinal problems. --more 22 18 Local Time 19 18 GMT
