Counterfeit versions of Alli, the over-the-counter formulation of the lipase inhibitor orlistat, contain sibutramine another weight loss agent, and could be “potentially harmful” for consumers, the Food and Drug Administration announced last month.
A statement posted on the agency's MedWatch site said orlistat manufacturer GlaxoSmithKline (GSK) had identified counterfeit versions of Alli 60-mgcapsules in the 120-count refill kit that do not contain orlistat. The counterfeit products contain sibutramine, a controlled substance that is marketed as Meridia by Abbott Laboratories. Sibutramine's therapeutic effects result from norepinephrine, serotonin, and dopamine reuptake inhibitionoaccording to the label.
Suspected reports of counterfeit Alli products were first made in December 2009. GSK has determined that the counterfeit products have been sold over the Internet and that there is no evidence the counterfeit product has been sold through retail stores or other channels.
The differences between the counterfeit product and the real product include the lot code, packaging, and expiration date: The counterfeit product does not have a “Lot” code on the outer cardboard packaging and the plastic bottle has a slightly taller and wider cap, with “coarser ribbing” than the authentic product.
In addition, the expiration date on the counterfeit product includes the month day and year—such as 06162010–while the authentic product includes the month and year only—such as 06/10. The foil that seals the opening of the counterfeit bottle has no printed words, but this safety seal on the authentic product seal is printed with “SEALED for YOUR PROTECTION.” Finally, the counterfeit product contains a white powder, while the authentic capsules contain small white pellets.
Prescription orlistat is marketed as Xenical, and is available in a 120-mg dose. Alli, 60-mg, was approved for over the counter use in 2007.
People who believe they have a counterfeit Alli product should contact the FDA's Office of Criminal Investigations at 800-551-3989 or www.fda.gov/OCImakewww.fda.gov/medwatch