UPDATE - Alli 60 mg capsules : Counterfeit Product containing undeclared drug, sibutramine, in up to 3 times usual daily dose

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: UPDATE - Alli 60 mg capsules : Counterfeit Product containing undeclared drug, sibutramine, in up to 3 times usual daily dose

Alli 60 mg capsules (120 count refill kit): Counterfeit Product

Audience: Consumers, Pharmacy healthcare professionals

[UPDATE 01/23/2010] FDA updated January 18 alert with information on laboratory analysis of sibutramine levels in counterfeit product.

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.

Read the MedWatch 2010 Safety summary including a link to both the original January 18 alert and the Update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm

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