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FDA warns of counterfeit weight-loss drug
Counterfeit version may contain sibutramine, not orlistat.
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The FDA has warned health care professionals and consumers of a counterfeit version of the over-the-counter weight-loss product, orlistat.
According to FDA laboratory tests, people who use the counterfeit product may be taking three times the usually daily dose, or twice the recommended maximum dose, of sibutramine if they are following the dosing directions for Alli, the FDA-approved orlistat marketed by GlaxoSmithKline.
POn Jan. 18, the FDA announced that preliminary tests revealed that the counterfeit version does not contain orlistat - the active ingredient in the product - but instead contains sibutramine.
The counterfeit Alli has been sold over the internet in 60-mg capsules as part of a 120-count refill kit.
The FDA warns that sibutramine should not be used in certain patient populations or without physician consent because it may counteract with other medications.
Moreover, the amount of sibutramine in the counterfeit product may be associated with anxiety, nausea, heart palpitations, tachycarida, insomnia and small increases in blood pressure. This excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease, and may lead to hypertension, stroke or myocardial infarction.
GlaxoSmithKline received consumer reports of the counterfeit product in December. It is not clear whether the counterfeit version has been sold in other channels, such as retail stores.
Differences in packaging between the counterfeit and authentic product include:
- Missing lot code on outer cardboard packaging
- Expiration date with the month, day and year (e.g., 06162010) whereas the authentic Alli expiration date includes only the month and year (e.g., 05/12);
- Packaging in a plastic bottle with a slightly taller and wider cap with coarser ribbing;
- Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “Sealed for your protection” and;
- Larger capsules with a white powder, instead of small white pellets.
The FDA advised consumers to contact the FDA’s Office of Criminal Investigations if they suspect they have received counterfeit Alli by calling (800)-551-3989 or by visiting www.fda.gov/OCI. In addition, health care professionals and consumers are advised to report any adverse events to the FDA’s MedWatch Program.