The Food and Drug Administration (FDA) is warning the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at online auction sites.
The counterfeit product is illegal and unsafe. FDA advises people who believe that they have a counterfeit product not to use the drug and to dispose of it immediately. There is no evidence at this time that the counterfeit Alli product has been sold in retail stores.
According to the FDA, the counterfeit Alli looks similar to the authentic product, with a few notable differences. Counterfeit Alli has:
* a missing LOT code on the outer cardboard packaging
* an expiration date that includes a month, day and year (real Alli only has month and year)
* plain foil for the inner safety seal without words on it (real Alli has the words “SEALED FOR YOUR PROTECTION” printed on it)
* large capsules with white powder, as opposed to small white pellets found in real Alli
* a slightly taller plastic bottle with a wider cap and coarser ribbing on cap than is seen in real Alli.
Alli is an FDA-approved, over-the-counter weight-loss drug that contains orlistat as its active ingredient. The counterfeit version does not contain orlistat, instead 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. Preliminary lab tests revealed the counterfeit version contained sibutramine and not orlistat. Since then, FDA lab tests on the counterfeit product show that people may be taking three times the usual daily does (twice the recommended maximum dose ) of sibutramine if they are following the dosing directions for Alli. Side effects from excessive sibutramine include elevated blood pressure, stroke and heart attack if you have a history of heart disease; and anxiety, nausea, heart palpitations, racing heart, insomnia and small increases in blood pressure if you are healthy.
If you have been taking the counterfeit product, stop taking the drug and throw it away; contact your health provider if you are experiencing more than mild symptoms, especially if you have a history of cardiovascular disease; and call FDA’s Office of Criminal Investigations at 800-551-3989 or by visiting the OCI Web site