FDA Warns of Counterfeit Alli Weight-Loss Drug

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.

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.