In 1999, Roche Laboratories, Inc. received marketing approval for orlistat (brand name: Xenical®) and has sold it as a prescription drug since. This afternoon, an FDA advisory panel is considering making a lower-dose version (60 mg. capsules, prescription strength is 120 mg. capsules) available for sale over-the-counter (OTC), without a prescription.
Xenical works locally in the digestive tract to block absorption of about 25% to 30% of the fat in a meal. One of the FDA's concerns is that the drug would also block absorption of fat-soluble vitamins E, D, K, and beta-carotene.
The FDA lists the most common side effects of orlistat as:
- Oily spotting
- Gas with discharge
- Fecal urgency
- Fatty/oily stools
- Frequent bowel movements
If approved, GSK will market the 60 mg. OTC version of orlistat as "Alli", pronounced ally - a reference to its use as an ally or helper in a total weight-loss program.
For an FDA Fact Sheet on Xenical (open as a pdf file):
For some news summaries:
FDA Mulling OTC Sale of Fat Blocking Pill
FDA Finds Risk in GlaxoSmithKline PLC's Xenical Diet Pill