It also warns about the risk of obtaining drugs that may contain sibutramine, component molecule of Sibutral, outside the pharmaceutical circuit. The European Medicines Agency (EMA) is preparing an evaluation of Sibutral, scheduled for January 2010.
Pending the conclusions of this evaluation, Afssaps reminds that the duration of treatment of Sibutral should not exceed one year. This medicine should not be prescribed to patients with a history of cardiovascular disease or to patients with insufficiently controlled hypertension.
The agency reminds that blood pressure and heart rate should be monitored regularly during treatment. It indicates that it has prohibited the preparation, prescription and delivery of preparations made by pharmacists containing sibutramine.
In 2002, the laboratory marketing this drug carried out a study on the impact of sibutramine in people with cardiovascular risk factors. Since that date, in France, this drug can only be prescribed by specialists or departments specializing in endocrinology, metabolic diseases and cardiology.
Sibutral is part of a program to control the weight of obese patients, whose body mass index is over 30.
