Pharmaceutical giant Roche Holding AG had hoped for a smooth approval of Xenical as the first over-the-counter (OTC) weight-loss drug. Xenical is manufactured by Roche Pharmaceuticals (a unit of Roche Holding AG) and is the higher-dose version of the OTC spin-off that will be sold under the name orlistat.
Once an FDA advisory committee had voted 11-3 to recommend the OTC version of Xenical for marketing, Roche had assumed final approval was assured. Now, however, that pathway seems less sure.
Side-effects associated with weight-loss drugs in general and their potential for abuse by those who are only slightly overweight are serious concerns. In addition, such drugs are often taken by people with a number of complicating medical problems (diabetes, cardiovascular disease, hypertension, elevated cholesterol, etc.) for which they are already taking a number of other powerful medications.
The FDA is also in the spotlight because of the high number of drugs pulled from the market in recent years as well as the ongoing litigation involving many of those once highly touted failures.
Now, in addition to the cautionary approach being taken by the FDA on its own comes the petition by the highly respected consumer watchdog organization, Public Citizen, seeking to have even the prescription form of the drug pulled from the market.
The petition filed with the FDA has been joined in by researchers from Case Western Reserve University School of Medicine who maintain that Xenical is linked to pre-cancerous changes in the lining of the intestinal tract. Animal studies from as far back as 1997 are cited as evidence that the drug produces an increase in the incidence of Ã¢â‚¬Å“aberrant crypt fociÃ¢â‚¬Â in rats. Such increases are believed to be a precursor of colon cancer.
A review of reported post-approval side-effects conducted by the group found 28 cases of breast cancer in patients taking Xenical.
Public Citizen also raises other concerns including the minimal efficacy of the drug, its known and potentially serious side-effects, and its potential for abuse as reasons to have the drug taken off the market. The group sees the proliferation of the drug in an OTC form as virtually guaranteeing an increase in the incidence of cancer.
Roche has not commented on the petition or the FDAÃ¢â‚¬â„¢s request for additional information relative to the OTC application. Nonetheless, Roche has taken the position that it still intends to market orlistat as an OTC weight-loss drug by the end of 2006.