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 orlistat |
| Alli |
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Pharmaceutical
company:
GlaxoSmithKline
www.gsk.com |
NEW WARNING
The Food and Drug Administration is warning consumers about a counterfeit, possibly harmful version of the OTC weight-loss product Alli 60 mg capsules. Preliminary laboratory tests conducted by GlaxoSmithKline (GSK), the product's manufacturer, revealed that the counterfeit product didn't contain orlistat, the active ingredient in Alli. The counterfeit product contained the controlled substance sibutramine instead. Sibutramine is a drug that shouldn't be used in certain patient populations or without physician supervision. Sibutramine can also interact dangerously with other medications the consumer may be taking.
Beginning early December 2009, consumers began reporting suspected counterfeit Alli, which was sold over the Internet, to GSK. There is no evidence that this product was sold in retail stores. The counterfeit product has a similar appearance to the authentic product with a few notable differences, including:
- The "Lot" code is missing from the outside cardboard package.
- The expiration date contains the month, day, and year. (The authentic product contains only the month and year.)
- Plain foil seals the plastic bottle. (The foil sealing the authentic bottle contains the printing "SEALED for YOUR PROTECTION.")
- The plastic container is taller and has a wider cap with coarser ribbing than the authentic product.
- The capsules are larger and contain a white powder. (The authentic product contains small white pellets.)
If you believe you have received the counterfeit product, contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989.
Health care professionals and consumers should report adverse events that may be associated with the use of these counterfeit products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
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