Warning: Counterfeit diet drug potentially harmful

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The federal government warned consumers today of a counterfeit over-the-counter diet drug recently discovered.

Lab tests have revealed that a version of the 60-milligram capsules of Alli does not contain orlistat, the active ingredient in the widely-marketed weight-loss drug, but instead contained the controlled substance sibutramine, according to the U.S. Food and Drug Administration.

Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

Consumers began reporting suspected counterfeit Alli to its manufacturer, GlaxoSmithKline, in early December. The company has determined the counterfeit product has been sold over the internet, as the 120 count refill version.

There is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores, the FDA said.

The fake 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."

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

Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations at 800-551-3989 or its Web site at www.fda.gov/OCI.

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