Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2022


By Sunil Verma

25th August, 2022

EMA recommends withdrawal of marketing authorisation for amfepramone medicines

EMA’s safety committee (PRAC) has recommended the withdrawal of EU marketing authorisations for amfepramone obesity medicines.

The recommendation follows a review which found that measures to restrict the use of these medicines for safety reasons have not been sufficiently effective. It found that the medicines were being used for longer than the recommended maximum period of 3 months, thereby potentially increasing the risk of serious side effects, such as pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) and dependency. The medicines were also being used in patients with a history of heart disease or psychiatric disorders, increasing their risk of heart and psychiatric problems. In addition, there was evidence of use during pregnancy, which could pose risks to the unborn baby.

The review considered all available information relating to these concerns, including data from a recent EMA study on the use of these medicines in Germany and in Denmark. In addition, the PRAC received advice from a group of experts, comprising endocrinologists, cardiologists and a patient representative.

The PRAC considered introducing further measures to minimise the risk of side effects but could not identify any that would be sufficiently effective. The PRAC therefore concluded that the benefits of amfepramone medicines do not outweigh their risks and recommended that the medicines be removed from the market in the EU.

More information is available in EMA’s public health communication.

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