In continuation of the Danish Medicines Agency’s warning on 19 January 2010 against counterfeit versions of the weight-loss product Alli®, the Danish Medicines Agency would like to bring attention to the latest information on the counterfeit product.
The U.S. Food and Drug Administration (FDA) has issued a press release stating that analyses have shown that the product does not contain the active substance orlistat, which authentic Alli® contains, but that the product instead contains the active substance sibutramine.
The FDA’s analyses show that the sibutramine content in the counterfeit version varies and that it contains up to three times the normal daily dose for treatment with sibutramine and up to twice the recommended daily maximum dose. Furthermore, the FDA states that healthy people taking this excessive amount of sibutramine can risk side effects such as anxiety, nausea, heart palpitations, insomnia and small increases in blood pressure. It is also dangerous to people who have a history of cardiovascular disease.
The counterfeit versions of Alli® are sold via the internet, particularly at online auction sites.
In this connection, the Danish Medicines Agency would like to emphasise that there is currently only one licensed medicine with sibutramine on the Danish market (Reductil®). On 22 January 2010, the Danish Medicines Agency recommended doctors to stop prescribing sibutramine and patients treated with sibutramine to consult their general practitioner to discuss other weight-reducing treatment options. See the link to this recommendation concerning sibutramine in the factbox to the right.
You can also see a link to the FDA’s updated warning in the factbox to the right.
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, 25 January 2010