The recommendation comes after it emerged that measures to limit the use of these medicines were insufficient
The interventions of the drug agencies, both national, community and world, on some drugs follow one another. This time, the decision comes to the continental level with the blocking of this widely used drug. Here are the reasons for the decision.
The Ema Pharmacovigilance Committee, the European Medicines Agency, has recommended the withdrawal of EU marketing authorizations for amfepramone-based obesity medicines.
According to the latest studies by the World Health Organization, in the Old Continent, 59% of adults and almost 30% of children are affected by obesity (29% of males and 27% of females). Pathology that causes more than 1.2 million deaths a year, corresponding to over 13% of total mortality in the area.
A serious disease in itself, but one that causes others, even more lethal. In fact, the risk of cancer, cardiovascular disease, type 2 diabetes, chronic respiratory diseases increases. The WHO report notes that overweight and obesity rates have reached epidemic proportions across the region and are still rising.
The motivations
The recommendation follows a review which revealed that measures to limit the use of these medicines for safety reasons have not been sufficiently effective..
The review considered all available information regarding different types of concerns raised, including data from a recent EMA study on the use of these medicines. The nations most under the magnifying glass, Germany and Denmark.
In addition, the committee (Prac) received advice from a group of experts, consisting of endocrinologists, cardiologists and a patient representative. The Prac had considered the introduction of further measures to minimize the risk of side effects, but was unable to identify one that was sufficiently effective.
It would have emerged that the drugs – explains the EMA in a note – were used for a longer period than the recommended maximum of 3 months. And science says this potentially increased the risk of serious side effects, such as pulmonary arterial hypertension and addiction.
The medicines were also used in patients with a history of heart disease or psychiatric disorders. And even in this case the risk of heart and psychiatric problems increased exponentially.
Additionally, there was evidence of use during pregnancy, which could pose risks to the unborn baby. He therefore concluded that the benefits of amfepramone medicines do not outweigh the risks and recommended that the medicines be withdrawn from the market in the EU.