For those interested in either the detailed description of the approved use of the diet drug Acomplia (rimonabant) in Europe, or the lay version that is found on the leaflet included in the drug package, we have obtained both from the the European Medicines Agency (EMEA) website.

The Summary of Product Characteristics (SPC) approved by the EMEA, which governs the conditions of use of Acomplia in the European Community and its 25 member states, can be read by clicking here.

An exact copy of the Package Insert Leaflet (PIL), which must be consistent with the SPC in a wording that can be easily understood by non-professionals, can be read by clicking here.

While a lot has been written about the target patient group for Acomplia -- obese patients (BMI of 30) or seriously overweight persons (BMI of 27 or more) with cholesterol problems or showing signs of developing type 2 diabetes -- the SPC makes it clearer who should NOT even be thinking about taking Acomplia.

The SPC says:

• Acomplia is NOT recommended for anyone below the age of 18.
• Acomplia should NOT be taken by any woman during pregnancy.
• Acomplia should NOT be taken by any woman who is breast-feeding.
• Acomplia should NOT be taken by anyone suffering from major depression (or any serious psychiatric condition).
• Acomplia is NOT recommended for persons who are taking antidepressant medication.
• Acomplia is not recommended for persons with severe kidney probems.
• Acomplia is NOT recommended for persons with severe liver problems.
• Acomplia should NOT be taken by anyone who is lactose intolerant.

In total, this bounds a pretty large universe of persons -- many of them overweight or obese -- who may not realise that they are NOT candidates for Acomplia.

The SPC also goes into considerable detail about possible side-effects of taking Acomplia, and the frequency with which they are likely to be encountered.

Anyone seriously interested in Acomplia would do well to read both the Summary of Product Characterists and the Package Insert Leaflet.