Consumers alerted to risks presented by counterfeit Alli.
A statement on the agency's Med-Watch site said orlistat manufacturer GlaxoSmithKline (GSK) had identified counterfeit versions of Alli 60-mg capsules in the 120-count refill kit that do not contain orlistat. The counterfeits contain sibutramine, a controlled substance that is marketed as Meridia by Abbott Laboratories. Sibutramine's therapeutic effects result from norepinephrine, serotonin, and dopamine reuptake inhibition, according to the label.
"Sibutramine is a drug that should not be used in certain patient populations or without physician oversight," and it can interact with other drugs, the FDA statement noted.
Suspected reports of counterfeit Alli products were first made in December 2009. GSK has determined that the counterfeit products have been sold over the Internet and there is no evidence the counterfeit product has been sold through retail stores or other channels.
The differences between the counterfeit and the real products include the lot code, packaging, and expiration date: The counterfeit product does not have a "Lot" code on the outer cardboard packaging and the plastic bottle has a slightly taller and wider cap, with "coarser ribbing" than the authentic product.
In addition, the expiration date on the counterfeit product includes the month, day, and year, whereas the authentic product includes the month and year only. The foil that seals the opening of the counterfeit bottle has no printed words, but this safety seal on the authentic product seal is printed with "SEALED for YOUR PROTECTION." Finally, the counterfeit product contains a white powder, whereas the authentic capsules contain small white pellets.
The prescription formulation of orlistat is marketed as Xenical, and is available in a 120-mg dose. Alli was approved in a 60-mg dose for over-the-counter use in 2007.
People who think they have a counterfeit Alli product should contact the FDA's Office of Criminal Investigations, 800-551-3989 or www.fda.gov/OCI. Adverse events possibly related to counterfeit products should be reported to the FDA's MedWatch Program, 800-332-1088 or www.fda.gov/medwatch.
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|Title Annotation:||NEWS FROM THE FDA|
|Publication:||Clinical Psychiatry News|
|Date:||Mar 1, 2010|
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