The US Food and Drug Administration is warning consumers about a counterfeit and potentially harmful version of an over-the-counter weight loss product.
Preliminary laboratory tests conducted by GlaxoSmithKline (GSK), the manufacturer of Alli 60mg capsules (120 count refill kit), revealed that the counterfeit version did not contain the product's active ingredient orlistat. Instead, it contained the controlled substance sibutramine, a drug that should not be used in certain patient populations or without supervision by a GP. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.
Consumers started reporting suspected counterfeit Alli to GSK in December 2009. The drugmaker says the counterfeit product has been sold via the Internet. As yet there is no evidence that the counterfeit product has been sold through other channels, such as retail pharmacists.
The counterfeit product looks similar to the authentic product, with a few notable differences.
The counterfeit Alli has:
Outer cardboard packaging missing a Lot. code;
An expiration date that includes the month, day and year (e.g. 06162010) - the authentic Alli expiration date includes only the month and year (e.g. 05/12);
Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
A 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.