FDA: Be aware of fake Alli

Tuesday Jan 20, 2010 (foodconsumer.org) -- On January 18, the Food and Drug Administration issued a warning alerting consumers to a counterfeit version of Alli 60 mg capsules (120 count refill kit). 

Alli is a FDA approved over-the-counter weight loss product. 

Tests by GlaxoSmithKline, the maker of Alli, found that the counterfeit product does not contain orlistat, the active ingredient in Alli. 

Instead, Glaxo was able to find an ingredient used in a competitor's weight loss product called sibutramine. 

Sibutramine is the active ingredient used in drugs like Reductil, Medidia and Sibutrex, manufactured by Abbott Laboratories and indicated to treat obesity. 

Alli works to prevent absorption of fat by the body while Sibutramine works to suppress appetite. 

Side effects of Sibutramine include  increased risk of cardiovascular events, dry mouth, increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing or joint/muscle pain. 

Orlistat, the active ingredient in Alli, has also been linked to certain liver injuries.  Between 1999 and 2008, the FDA has received 32 reports of serious liver injuries in patients taking Glaxo's weight product.  Of thoses case, 27 were hospitalized and six suffered liver failure. 

Glaxo started receiving reports of counterfeit Alli in early December 2009. The product was said to have been sold over the internet, but not though other channels such as retail stores. 

The FDA did not say consumers who have the fake Alli should not take it, but rather, that consumers who believe they have received counterfeit Alli should contact the FDA by calling 800-551-3989.

Reporting by Jimmy Downs and editing by Rachel Stockton