FDA warns consumers about counterfeit Alli

ROCKVILLE, Md. The Food and Drug Administration on Monday issued a warning to consumers about a counterfeit and potentially harmful version of the over-the-counter weight-loss medicine Alli 60-mg capsules.

Preliminary laboratory tests conducted by GlaxoSmithKline — maker of Alli — revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight.

Sibutramine also can interact in a harmful way with other medications the consumer may be taking.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the Internet. If a retailer has only purchased product from GSK there should be no cause for concern, GSK stated. “There is no evidence that counterfeit Alli products have penetrated other distribution channels [outside of Internet sites],” GSK added. However, there is no evidence at this time that the counterfeit Alli product has been sold through other such channels as retail stores.

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

• Outer cardboard packaging missing a “Lot” code;
• Expiration date that includes the month, day and year (e.g., 06162010) — authentic Alli expiration date includes only the month and year (e.g., 05/12);
• 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;” and
• Contains larger capsules with a white powder, instead of small white pellets.