FDA Warning: Counterfeit Alli weight-loss drug on the market

Legal news for product liability attorneys. The FDA is warning consumers that counterfeit Alli is being sold.

Food and Drug Administration (FDA) alerts product liability lawyers- FDA is warning consumers of a counterfeit over-the-counter weight loss product.

West Palm Beach, FL—The U.S. Food and Drug Administration (FDA) http://www.fda.gov issued an alert to consumers that counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit) are on the market, as reported by the FDA.

GlaxoSmithKline (GSK), the maker of Alli, conducted preliminary laboratory tests on the over-the-counter weight-loss product, which showed that the counterfeit version did not contain orlistat, one of the products active ingredients. The counterfeit Alli instead contains a controlled substance called sibutramine. Sibutramine can cause a harmful interaction with other medications in which the consumer may be taking. The ingredient also cannot be used in certain patient populations or without physician oversight. Reports of counterfeit Alli were documented in early December 2009. The counterfeit product was sold over the Internet, but the drug may have also been sold through other channels as well.

The FDA reported that the counterfeit Alli looks very similar to the real product, with the exception of a few differences like:

• 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.

Any consumers who believe they have the counterfeit Alli are urged to contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).
Health care professionals and consumers are also asked to report any adverse events that may be related to the use of the counterfeit Alli to the FDA’s MedWatch Program 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.

Legal News Reporter: Nicole Howley-Legal news for product liability attorneys.