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FDA Warns Consumers About Counterfeit Alli

Fake diet pill can cause serious health problems

By James Limbach
ConsumerAffairs.com

January 18, 2010

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The Food and Drug Administration (FDA) is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).

Preliminary laboratory tests conducted by GlaxoSmithKline (GSK) -- the maker of the FDA approved over-the-counter weight-loss product -- revealed that the counterfeit version did not contain orlistat, the active ingredient in its product.

Instead, it contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. It can also interact in a harmful way with other medications the consumer may be taking.

Even the real product has been the subject of complaints:

• Terry of Deer Park, NY tells ConsumerAffairs.com, "The product Alli caused extreme stomach pains and the company is denying anyone else having this symptom. I tried to enter a warning on the message board of their website as a member of the program and was denied entry stating that my message was too negative to post." Terry says she is still experiencing problems with stomach pain and that she doesn't know yet if Alli has caused permanent damage to her body.

• Diana of Glen Allen, VA writes that she used the Alli product to lose weight and after three days a got costocondritis and got big medical bills that she cannot afford to pay. "I get better when stop having Alli pill," she adds.

Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. The company has determined that the counterfeit product has been sold over the Internet. However, there is no evidence at this time that the counterfeit Alli has been sold through other channels, such as retail stores.

The bogus Alli 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";

• Contains larger capsules with a white powder, instead of small white pellets.

Consumers who believe they have received counterfeit Alli may contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the Web site.

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