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Counterfeit ALLI - FDA alert

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I hope no one is using Alli since we need the good fats for heart and

cholesterol health - and Alli blocks all fats. But for those interested..

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

January 23, 2010

[uPDATE 01/23/2010] FDA updated January 18 alert with information on laboratory

analysis of sibutramine levels in counterfeit product.

FDA notified consumers and healthcare professionals about a counterfeit and

potentially harmful version of Alli 60 mg capsules (120 count refill kit). The

counterfeit version contained the controlled substance sibutramine and did not

contain orlistat, the active ingredient. Sibutramine is a drug that should not

be used in certain patient populations or without physician oversight.

Sibutramine can also interact in a harmful way with other medications the

consumer may be taking. GSK has determined that the counterfeit product has been

sold over the internet. However, there is no evidence at this time that the

counterfeit Alli product has been sold through other channels, such as retail

stores. The differences between the counterfeit and authentic products are

described in both text and photos in the FDA news release.

Consumers who believe they have received counterfeit Alli are asked to contact

the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by

visiting the OCI Web site (http://www.fda.gov/OCI).

Any adverse events that may be related to use should be reported to the FDA's

MedWatch Safety Information and Adverse Event Reporting Program online [at

www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the

postage-paid FDA form 3500 [which may be downloaded from the MedWatch " Download

Forms " page] by mail [to address on the pre-addressed form] or fax

[1-800-FDA-0178].

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