Following the recommendation of the European Medicines Agency (EMA) to suspend the marketing authorization of medicines containing sibutramine, the firm Abbott, at the request of the Federal Agency for Medicines and Health Products (FAMHP), withdrew Reductil from the market (the only medicine with sibutramine approved and marketed in Belgium) for security reasons. The FAMHP stresses the danger of buying online medicines with sibutramine.
The EMA has reassessed the safety of sibutramine, a drug used for fighting overweight. The Committee for Medicinal Products for Human Use (CHMP) of the EMA concluded that the cardiovascular risks associated with the use of this drug outweigh its benefits and recommended the suspension of the marketing authorisation (MA) of medicines containing sibutramine throughout the European Union.
Following the recommendation of the EMA and on request of FAMHP, the firm Abbott stopped marketing Reductil, the only medicine with sibutramine that was approved and marketed in Belgium, and has initiated the recall of the packs available in the pharmaceutical distribution channels (see communiqué dated 22/01/2010).
It appears that medicines with sibutramine are available on the internet.
The FAMHP reminds people of the danger of buying medicines via the Internet outside the legal distribution channels.Medicines offered for sale on the internet via illegal sites can be counterfeit or forged.Some sites also offer illegal sale of slimming products; some are so-called herbal, but in fact fraudulently contain sibutramine.
Unfortunately it is difficult for authorities to identify those persons responsible for such illegal sites, often operating outside the Belgian territory, and to stop their illegal activity.
This warning against buying medicines via the internet, outside the legal distribution channels, has been in 2009 part of the FAMHP campaign “Medicines on the internet! Do not surf with your health!”
The FAMHP insists that outside the legal distribution channels, quality, safety and efficacy of medicines cannot be guaranteed because the medicines are beyond the control of the authorities.
Buying on the internet medicines that are unavailable in Belgium puts people at risk of using medicines that were withdrawn from the market because of their negative benefit / risk balance.This is the case of sibutramine.
Purchasing on the internet deprives the patient of the advice of his doctor and pharmacist.
The FAMHP finally reminds people that obtaining via the internet medicines that are in Belgium not (or no more) permitted or under prescription is forbidden and is subject to penal sanctions and seizure of goods.
The medicines with sibutramine approved in the European Union, are known uder the following trade names: Afibon, Ectiva, Lindaxa, Meiss, Meridia, Minimacin, Minimectil, Obesan, SibutraSitrane, Redoxade, Reductil, and Zelixa Zelium.