AIFA Agenzia Italiana del Farmaco
EMA confirms the recommendation to withdraw marketing authorisations for amfepramone-based medicines
The EMA Safety Committee (PRAC) has confirmed the recommendation to withdraw EU marketing authorisations for amfepramone-based obesity medicines. This follows the review of the previous PRAC recommendation of June 2022, requested by marketing authorisation holders.
These medicines are not authorised in Italy*.
The recommendation follows a review which showed that measures to restrict the use of these medicines for safety reasons have not been sufficiently effective.It was found that the medicines are taken for longer than the maximum recommended period of 3 months, thus potentially increasing the risk of serious side effects, such as pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) and dependence. The medicines are also used in patients with a history of heart disease or psychiatric disorders, increasing the risk of heart and psychiatric problems. In addition, there is evidence of use during pregnancy, leading to potential risks for the unborn child.
More information can be found in the EMA communication available in the «Related documents».
*In Italy, the manufacture, import, marketing, prescription and dispensing of amfepramone (diethylpropion) are prohibited, according to ministerial decree of 2 August 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 substances subject to abuse with addictive power.
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Source — https://www.univadis.it/viewarticle/ema-conferma-la-raccomandazione-di-ritirare-le-autorizzazioni-allimmissione-in-commercio-per-i-medicinali-a-base-di-amfepramone