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news.The FDA has issued an alert to consumers about a counterfeit and potentially harmful version of Alli 60mg capsules (120 count refill kit).
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Alli 60mg capsule is indicated for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie, low-fat diet.
Preliminary laboratory tests conducted by GlaxoSmithKline (GSK), the maker of the FDA approved over-the-counter (OTC) weight-loss product, has revealed that the counterfeit version did not contain orlistat, the active ingredient in its product.
However, the counterfeit product contains the controlled substance, sibutramine. 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.
The FDA said that the consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet.