Monday, January 23, 2006

FDA Considers OTC Version of the Fat-blocker Xenical

Xenical® may become the first government-approved weight-loss drug available without a prescription.

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
In 2004, GlaxoSmithKline (GSK) acquired the OTC marketing rights for orlistat from Roche. In 2005, Roche teamed with GSK to copromote Xenical in the US.

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):
Xenical (orlistat)

For some news summaries:
FDA Mulling OTC Sale of Fat Blocking Pill
FDA Finds Risk in GlaxoSmithKline PLC's Xenical Diet Pill