FDA Warns of Counterfeit Alli

The FDA has issued a warning that a circulating counterfeit version of GlaxoSmithKline’s over-the-counter diet pills Alli may contain the controlled substance sibutramine.

The warning concerns counterfeits of the diet pill Alli 60 mg capsules (120 count refill kit). In a press release issued last week, the FDA warned that preliminary results from tests done by GlaxoSmithKline, maker of Alli, found that the counterfeit pills contain sibutramine in place of the product’s active ingredient orlistat.

Sibutramine, also known as Meridia, is an appetite suppressant used to treat obesity. If improperly used without the advice of a licensed physician and pharmacist, it may lead to gastrointestinal problems, heart failure, renal failure and even death. Sibutramine can also interact in a harmful way with other medications.

Consumers began reporting the counterfeit product last year. So far, the counterfeit Alli has only been sold online, and neither the FDA nor GlaxoSmithKline has found evidence or heard reports that it is being sold through retail stores or any other means. The counterfeit Alli appears similar to the genuine product but with the following key differences:

• The outer cardboard packaging on the counterfeit Alli is missing a Lot code.
• The expiration date on the counterfeit includes the month, day and year; a real Alli expiration date only contains the month and year.
• The counterfeit is packaged in a plastic bottle with a slightly taller and wider cap with coarser ribbing than the genuine product.
• The counterfeit has a plain foil inner safety seal under the plastic cap without any printed words; an authentic Alli seal is printed with the words “SEALED for YOUR PROTECTION.”
• Counterfeit capsules are larger than the genuine Alli and contain a white powder. Genuine Alli capsules contain small white pellets.

Picture-by-picture comparisons of the real Alli and the counterfeit Alli are available on the FDA website and GlaxoSmithKline’s official consumer information page for Alli, MyAlli.com.

So far consumers who have taken the counterfeit product are reporting stronger versions of the gastrointestinal-related side effects associated with authentic Alli. Consumers should only purchase Alli from reputable stores or their branded online stores, GlaxoSmithKline said. If you feel that you may have purchased the counterfeit product, please contact the FDA Office of Criminal Investigations (OCI) at 800-551-3989, or go online to the OCI Web site. If, for any reason, you feel you may have taken the counterfeit product, contact your local pharmacist or your personal physician immediately.