Just yesterday, the news came that the Safety Committee of the EMA strongly wants to block the authorization of an anti-obesity drug in the EU market.
It is about medicines based on a substance, theamfepramoneconsidered to have a high addictive power.
But let’s try to better understand how the EMA does not want these drugs to obtain theauthorization for entry into Europe. The “strong recommendation” comes after one revision from which it emerges that there are insufficient safety conditions in taking drugs of this type.
L’obesity it’s a problem that afflicts adults and especially children from all over the world. Contrary to what one might think, even in developing countries. As far as Europe is concerned, as early as 2014 Eurostat estimated that 51.6% of the population was overweight. Children affected by this dangerous condition are at least 1 in 3 across the EU.
Let’s imagine how this has grown again phenomenonthat it is concerned precisely with the important repercussions on people’s general health. In addition to physical diseases, in fact, overweight / obesity can also lead to the onset of a wide range of psychological disordersfirst of all the depression.
L’Europa thus began a “Battle” against obesity, through multiple strategies. The various projects deal with the different aspects that lead to this condition. From the congenital factor at incorrect information described in food labels. From the conception of neural interfaces to help people lose weight up to creation of natural and / or medicinal preparations to “cure” the condition. Unfortunately, sometimes something can go wrong.
EMA blocks European authorization for anti-obesity drug, that’s why
Let’s talk about medicines based on a substance, theamfepramone. For the record, let’s just say that amfepramone-based drugs (diethylpropion) in Italy “are prohibited, according to the ministerial decree 2/8/2011, published in the Official Gazette no. 180 of 4 August 2011, which ordered the placement of amfepramone in Table I of Presidential Decree 309/1990 and subsequent amendments, among the abused substances with addictive power“.
Practically, the use of the above substances causes serious side effects and the risk is that people fail to stick to proper use, becoming then “Addicted” to these substances. The risk, as is well understood, is therefore too high compared to the benefit that the drug can offer to combat obesity.
During a review of authorizationsthe EMA Safety Committee (PRAC) found that “measures to restrict the use of these medicines for safety reasons have not been sufficiently effective. Medicines are taken for longer than the recommended maximum period of 3 months, thus potentially increasing the risk of serious side effectssuch as pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) e dependence“.
So, in addition to the addictive aspect, there is also that of side effects of the drug itself. The Committee’s conclusions come after in-depth analyzes. They were also taken into consideration two studies carried out in Denmark and Germany concerning the use of amfepramone-based medicines. The results showed that both pathologies went away in patients suffering from psychiatric disorders and / or heart disease getting worse.
The PRAC thus concluded that the risk / benefit ratio is not balanced and so he decided to recommend the withdrawal of the marketing authorization of these antiobesity medicines in Europa.