France bans sibutramine for obesity in advance of expected Europe-wide ban

Obesity illustration: Combined Media (CC)

Sibutramine, the controversial appetite suppressing drug used by many obese patients in the USA, is said to pose excessive risks of cardiovascular and other complications.

The sibutramine ban may be received as very bad news for obese French and European citizens who, due to stringent health safeguards, already have a very limited range of legal drugs available to help them lose weight.

France’s Agency for the Sanitary Safety of Health Products (AFSSAPS) decided this week  to take sibutramine –- sold in France since 2001 under the brand name Sibutral –- off the list of approved prescriptions in advance of an upcoming Europe-wide decision on its safety risks by the EU’s health commission. It is widely expected that the drug will be banned in European countries. Great Britain has already suspended its use.

Long-term studies carried out by the AFSSAPS claim that sibutramine can cause undesirable cardiovascular effects in almost half of patients who use it. Other side effects include blood pressure increase, stomach and muscle pain, nausea, and mental mood changes, including depression. There are also many contraindications associated with sibutramine which mean that prescribing it can be fraught with difficulty.

Examples of sibutramine poisoning in Europe have also been uncovered. They have been caused by illegal imports of dangerous dietary supplements principally imported from China, the Far East and Africa.

Another nail in the coffin for sibutramine comes in the form of a decision by the heavily influential London-based European Medicines Agency (EMA) which has also recommended the suspension of its use. The recommendation also includes other drugs containing sibutramine, such as Reductil, Reduxade and Zelium. Not only does the EMA say the drug presents risks which outweigh its benefits, but it also claims that it has a minimal weight-loss effect in most patients and that weight lost during sibutramine treatment is soon put on again when the patient stops using it. Both the AFSSAPS and the EMA are asking themselves how sibutramine -– produced by the American company Abbott –- was able to be legalised in Europe just a few years after other appetite-reducers such as dexfenfluramine and fenfluramine were banned for the same health concerns.

The only appetite-reducing drugs available legally in France at this time are the orlistat-based Xenical, which is produced by Roche, and Alli, another orlistat-based drug sold by GlaxoSmithKline. These drugs do not work in the same way as sibutramine. Sibutramine is a neurotransmitter reuptake inhibitor which gives the patient the impression of satiety, and orlistat works by preventing the absorption of fat. It also has many less secondary effects compared to sibutramine.

Sibutramine is also a controversial drug in the United States, where the FDA recently acknowledged concerns that it may increase the risk of heart attacks and strokes in patients with cardiovascular antecedents.