FDA Issues a Warning about Fake Alli Diet Drug

January 2010

Fake, potentially harmful versions of the weight loss drug Alli are being sold on Internet auction sites such as eBay, the Food and Drug Administration (FDA) warns. FDA lab tests found that the imitation pills contain three times the usual daily dose of a controlled substance that is the main ingredient in the prescription weight loss drug Meridia.

GlaxoSmithKline (GSK), which makes the approved version of Alli, said tests showed the falsely packaged and labeled products contained sibutramine, instead of orlistat, the main ingredient that should be in Alli. The FDA said the false version of Alli was sold in 60 mg capsules as part of a 120 count refill kit. There is currently no evidence that the fake product has been sold through channels other than online auction sites, such as retail stores, GSK said.

Healthy people who take an excess amount of sibutramine can experience anxiety, nausea, heart palpitations, tachycardia (a racing heart), insomnia, and small increases in blood pressure. Also, excessive amounts of the drug are dangerous to people with cardiovascular disease and can lead to elevated blood pressure, stroke, or heart attack. Sibutramine can also have harmful interactions with other medications.

According to GSK, there are several ways to identify counterfeit Alli:

• The fake version is missing the lot code on the top of the outer cardboard packaging.
• The expiration date on the false version includes the month, day, and year. The expiration date on the genuine version has only the month and year.
• The seal on the bottle should read "SEALED FOR YOUR PROTECTION" in white ink; this statement is not present on the fake product.
• The capsule size is slightly larger in the fake pills and the contents of the capsules are different – the counterfeit content is powdery and the genuine product is more of a pellet shape.

Pictures of the real and fake product can be seen on GlaxoSmithKline’s myalli.com web site. Consumers who suspect they have purchased counterfeit Alli are urged to contact the FDA.