FDA warns of counterfeit Alli

The Food and Drug Administration has issued a warning to consumers yesterday, January 18, 2009 about a counterfeit and potentially dangerous version of Alli 60mg capsules, a 120-count refill kit.

GlaxoSmithKline (GSK), the manufacturer of Alli, has conducted preliminary lab tests and discovered that the counterfeit version did not contain orlistat, the active ingredient in Alli. Instead, the counterfeit version contains the controlled substance sibutramine.

Sibutramine is an agent for the treatment of obesity as an appetite suppressant. Sibutramine is the active ingredient in brand name medications such as Reductil, Meridia and Sibutrex. It is classified as a Schedule IV controlled substance in the U.S.

Reports from consumers began to pour into GlaxoSmithKline in December 2009. GSK has determined that the counterfeit capsules are being sold over the Internet. There is no evidence at this time that the counterfeit Alli has reached retail stores or being sold through other channels.

The counterfeit product looks similar to the authentic Alli with a few differences. The counterfeit Alli has:

· The lot number is missing from the outer cardboard package
· The expiration date includes a month, day, and year; the authentic Alli expiration date includes only the month and year
· The foil safety seal does not have any printed words; the Alli foil seal is printed with “SEALED FOR YOUR PROTECTION”
· Contains larger capsules with white powder instead of small white pellets

Consumers who believe that they have received counterfeit Alli are being asked to contact the FDA’s Office of Criminal Investigations by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).