Counterfeit Alli Updated 2
A warning about a counterfeit and potentially harmful version of the popular over-the-counter weight loss pill
Alli was issued Monday by the U.S. Food and Drug Administration.
The agency said preliminary laboratory tests conduced by
Alli manufacturer GlaxoSmithKline revealed that the counterfeit version of
Alli 60 mg capsules (120 count refill kit) don't contain
orlistate, the active ingredient in the genuine product.
Instead, the counterfeit pills contain sibutramine, a drug that shouldn't be used by certain patients or without physician oversight, the FDA said. In addition, sibutramine may cause harmful interactions with other medications a patient takes.
The counterfeit version of
Alli was sold over the Internet. GlaxoSmithKline began receiving consumer reports of suspected counterfeit
Alli early last December.
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 [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].
While the counterfeit
Alli looks like the authentic product, a few notable differences exist, the FDA said. The counterfeit
Alli has:
* Outer cardboard packaging missing a "Lot" code.
* Expiration date that includes the month, day and year (e.g., 06162010). The expiration date on authentic includes only the month and year (for example, 05/12).
* Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product.
* Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with "SEALED for YOUR PROTECTION."
* Contains larger capsules with a white powder, instead of small white pellets.