FDA REJECTED PUBLIC CITIZEN PETITION IN APPROVING OTC WEIGHT-LOSS DRUG

The FDA denied Public Citizen's request to remove Roche's prescription weight-loss drug Xenical from the market over concerns it could contribute to colon cancer.

Public Citizen asked the FDA to remove Xenical (orlistat) from the market because of studies that suggested it caused an increase in aberrant crypt foci, which could be a precursor to colon cancer. The group cited seven studies investigating orlistat and the development of aberrant crypt foci that Roche included in its new drug application to the FDA. The studies show that Roche was worried about the link between the drug and colon cancer, Public Citizen said.

Making the drug available OTC would be "ill-advised" and would likely increase incidences of cancer, said the April 10, 2006, letter, posted recently to the FDA website.

The agency has also not sufficiently reviewed the risk that orlistat could contribute to breast cancer, the letter said.

The FDA responded to Public Citizen's letter Feb. 7, the same day the agency approved an OTC version of the drug. The agency said its review of available data of the drug's efficacy and safety do not warrant withdrawing the drug from the market. The available evidence does not support a causal relationship between orlistat and colon cancer, the FDA said.

The FDA said it would continue to monitor orlistat's safety while it is on the market.