The Danish Medicines Agency warns any consumers who have purchased the weight-loss product Alli® via American websites of the risk that the product may be counterfeit, and that the counterfeit version contains an active substance not listed on the package. The American Food and Drug Administration (FDA) has alerted the Danish Medicines Agency that American consumers have bought counterfeit Alli® on the internet.
The counterfeit version contains an active substance not listed in the product information, whereas it lacks the active substance orlistat, which is contained in the approved medicine. According to the FDA, the counterfeit package contains capsules with white powder instead of the approved capsules with pellets. Also, the inner foil safety seal under the plastic screw cap lacks the text of the authentic product: “SEALED for YOUR PROTECTION”. Furthermore, the expiry date is written differently than on the authentic version.
In the factbox to the right, there is a link to the FDA’s warning which contains further information as well as pictures comparing the counterfeit and the authentic product.
The Danish Medicines Agency would like to stress that it is not permitted to import medicine by post from the USA and other countries outside the EU/EEA. However, it cannot be ruled out that Danish consumers have bought and imported counterfeit versions of Alli® via American websites.
GlaxoSmithKline, which manufactures the approved medicine Alli®, has analysed the counterfeit version. Their laboratory tests reveal that the counterfeit product contains the active substance sibutramine, which is a constituent of an approved prescription-only medicine for treatment of obesity. Sibutramine affects neurotransmitters in the brain that regulate the appetite. Sibutramine also increases metabolism.
If you have bought Alli® online via an American website, the Danish Medicines Agency recommends that you:
- Check if the product characteristics mentioned suggest that it is a counterfeit version and if so, stop taking the product. This also applies if you are unsure whether the product is authentic or counterfeit.
- Contact your general practitioner, if you are concerned.
You can hand over any remaining counterfeit medicine to a pharmacy for destruction.
We also urge persons who buy medicine on the internet to be careful and to seek advice from their doctor before buying any medicines. The doctor may assess the effects and side effects of the product, including whether or not the product concerned would benefit the patient.
For further information, please contact pharmacist Lisbeth Lund Hemmingsen, tel.: +45 4488 9746, or lawyer Matilde Kyst Behrens, tel.: +45 4488 9183.
Danish Medicines Agency, 19 January 2010