A counterfeit and potentially harmful version of the popular weight loss drug Alli has been found on the Internet, and Food and Drug Administration (FDA) is warning consumers and healthcare providers to be on the look out for it. The drug in question is Alli 60 mg capsules (120-count refill kit). This counterfeit version contains the controlled substance sibutramine and did not contain orlistat, the active ingredient in Alli.  Sibutramine is a drug that should be used under physician supervision and should not be used among some individuals as it can interact in a harmful way with other medications.

Consumers first began contacting GlaxoSmithKline (GSK), which distributes Alli, with suspicions of counterfeit Alli. GSK has determined that the counterfeit product has been sold over the Internet, however there is no evidence that the counterfeit product hasn’t been sold through other channels, such as retail stores. The product boxes look similar at first glance, but the differences are listed below:

• Outer cardboard packaging missing a “lot” code.
• Expiration date that includes the month, day and year; authentic Alli expiration date includes only the month and year.
• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION.”
• Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have counterfeit Alli are asked to contact the FDA’s Office of Criminal Investigation at 800-551-3989 or www.fda.gov/OCI. Any adverse reactions to this or any drug should be reported to the FDA’s MedWatch Program at www.fdagov/MedWatch.