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Drug Information Update- UPDATED Public Health Alert: Counterfeit Alli containing sibutramine

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


The U.S. Food and Drug Administration (FDA) is updating its warning to the public about a counterfeit version of Alli 60 mg capsules (120 count refill pack) being sold over the internet, particularly at online auction sites. FDA advises people who believe that they have a counterfeit product not to use the drug and dispose of it immediately.

Additional FDA laboratory tests on the counterfeit product show that people may be taking 3-times the usual daily dose (or twice the recommended maximum dose) of sibutramine if they are following the dosing directions for Alli. Healthy people who take this much sibutramine can experience anxiety, nausea, heart palpitations, tachycardia (a racing heart), insomnia, and small increases in blood pressure. This excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease, and can lead to elevated blood pressure, stroke, or heart attack.

FDA recommends everybody check and make sure they are not taking counterfeit Alli. If they suspect they are taking the counterfeit product, they should stop taking the drug and dispose of it. People should contact their healthcare professionals if they have taken the counterfeit product and are experiencing more than mild side effects, especially if they have a history of cardiovascular disease.

For more information, please visit Counterfeit Alli Update


January 26, 2010 - Posted by | 1

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