FDA Warns of Counterfeit Alli Diet Pills

Consumers are being warned about fake and potentially harmful versions of the popular diet drug Alli being sold over the Internet.

Alli is the brand name form of the weight-loss drug orlistat, which also is available in prescription stength under the name Xenical. However, the counterfeit pills now making the rounds for sale on line contain sibutramine rather than orlistat, which may result in dangerous drug interactions and other adverse side effects in some users, the Food and Drug Administration said.

GlaxoSmithKline PLC, the maker of Alli, said sales of the counterfeit drug have been limited to Internet sites and bottles of the drug sold in retail stores are not affected by the warning, the FDA said. The warning involves 60 mg capsules in 120-count bottles.

Alli Linked to Liver Damage

Genuine Alli and Xenical are now being investigated by the FDA for possible links to liver failure and liver disease. From 1999 through October 2008, the FDA said it received 32 such reports from users of the two drugs, including six cases of liver failure and 27 cases in which patients required hospital treatment.

Consumers first reported counterfeit Alli to the company in early December 2009, officials said.

How to Spot Counterfeit Alli

The counterfeit Alli product looks similar to the authentic product, but there are a few notable differences, the FDA said. 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.

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