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Dr. Kim Mulvihill ReportingAn FDA advisory committee is considering whether to recommend making a weight loss drug available without a prescription.
Try to lose weight and anyone will tell you, it's just not that easy. Now the makers of Xenical or Orlistat, a popular prescription diet pill, want to make the ordeal easier. They asked for permission to sell a lower dose version over the counter.
Xenical works by blocking the absorption of fat. Clinical trials show some benefit, including weight loss and favorable changes in blood pressure, lipids and glucose levels. And while the FDA says the drug is safe and effective, there can be some unpleasant side effects, like gas, diarrhea, and the sudden loss of bowel control.
The makers believe the lower dose version will have fewer side effects. However, doctors still worry the drug could be abused or taken by people who won't change their diet. People using the drug need to reduce their intake of fat.
Patients also need to take a multivitamin. However, half of those in the clinical trial ignored this advice. And while the manufacturer says their drug is not a magic pill, that could be what most dieters want.
The company hopes to sell the drug under the name "Alli". The advisory panel's decision is only a recommendation. The FDA has the final say, although the agency usually follows the advice of its panel.
