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FDA Warning Issued Over Fake Alli Drug Sales

The U.S. Food and Drug Administration (FDA) has recently issued a warning about counterfeit Alli drug sales. The FDA warning details that the counterfeit version of the Alli drug has been sold online. The fake Alli drug could have potentially harmful effects if taken. According to the FDA warning, the fake Alli drug does not contain orlistat; which is the active ingredient in the authentic Alli drug.

Instead, the fake Alli drug contains the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without doctor supervision. According to the Wall Street Journal, it is the substance that is found in the diet drug Meridia. This particular substance is known to interact with other medications. While Alli can be taken over the counter, any drug with sibutramine should not. Another issue is that the drug Meridia should be taken once a day while Alli is taken three times a day. This exposes consumers to health risks.

The FDA has released that the maker of Alli, Glaxo Smith Kline (GSK) have received consumer complaints about possible fake Alli pills on the market since early December 2009. Some of the features of the counterfeit Alli are:

  • 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 (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

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