FDA Warns of Counterfeit Alli Weight-Loss Medication

The U.S. Food and Drug Administration (FDA) issued a warning for consumers on January 18, 2010, concerning their discovery of a potentially harmful counterfeit version of GlaxoSmithKline’s Alli 60 mg capsules in a 120-count refill kit.

The counterfeit Alli contains sibutramine instead of the ingredient orlistat that is found in the authentic version of the over-the-counter weight loss medication. Sibutramine is a component of the weight-loss drug Meridia and is a Schedule IV controlled substance under the U.S. Controlled Substances Act.

GlaxoSmithKline discovered the counterfeit version of Alli being sold over the Internet, and it is currently unknown where else the counterfeit version has been sold. The company first received reports of the counterfeit version in December 2009.

The counterfeit Alli capsules look similar to the authentic product, but the following differences have been noted on the counterfeit medication:

• Outer cardboard packaging does not have a printed “Lot” code
• Expiration date includes the month, day, and year (instead of the usual month and year only)
• Plastic bottle packaging has a slightly taller and wider cap with coarser ribbing
• Inner safety seal foil is plain and lacks the “Sealed for your protection” notice
• Capsules are larger and contain a white powder instead of white pellets

The FDA requests that consumers report any counterfeit Alli products in their possession to the FDA Office of Criminal Investigations by calling 800-551-3989 or by visiting the office’s Web site (http://www.fda.gov/OCI).

Adverse events experienced by those who have accidentally taken the counterfeit capsules should be reported to the FDA’s MedWatch program at 1-800-FDA-1088.