From FDA

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.

[Posted 01/18/2010] 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 [atwww.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].

UPDATED Public Health Alert: Counterfeit Alli containing sibutramine

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.

Alli is an FDA-approved over-the-counter weight loss drug that contains orlistat as its active ingredient.  The counterfeit version of Alli does not contain orlistat; rather, it is made with varying amounts of sibutramine, a stimulant drug.

Although sibutramine is the active ingredient in another FDA-approved prescription weight loss drug, it is only to be used in specific doses and under the supervision of a physician. The counterfeit product is illegal and unsafe.

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.

Although the counterfeit product looks very similar to Alli, this product can be identified by:

• A missing LOT code on the outer cardboard packaging. Photo examples
• An expiration date that includes a MONTH, DAY, and YEAR — the expiration date of the real product only contains a MONTH and a YEAR. Photo examples
• A plain foil for the inner safety seal without any words on it — the safety seal of the real product has the words “SEALED FOR YOUR PROTECTION” prominently printed on it. Photo examples
• The counterfeit product will also contain large capsules with white powder, as opposed to the small white pellets found in Alli. Photo examples
• People can also compare the product they bought over the internet to one purchased at a pharmacy. The plastic bottle of the counterfeit product will be slightly taller, have a wider cap, and coarser ribbing on the cap then what is seen with authentic Alli.

People who believe they have received counterfeit Alli should stop taking it immediately, dispose of it, and are asked to call the FDA's Office of Criminal Investigations (OCI) at 1-800-551-3989 or by visiting theOCI Web site. They can also contact GSK at 1 800 671 2554 if they believe they have purchased the counterfeit product.

People are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [atwww.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].