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Europe: EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines

2022/11/18  EMA

EMA’s safety committee (PRAC) confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was requested by the companies that market these 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 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 two studies on the use of amfepramone 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.

The CMDh agreed with the PRAC recommendation and adopted its position by majority on 10 November 2022.

Information for patients

  • EMA is recommending that amfepramone obesity medicines should no longer be available because they are not always used as recommended.
  • Inappropriate use can cause serious side effects, such as increased blood pressure in the arteries of the lungs, heart disease, dependency, psychiatric problems and harm to the unborn baby.
  • In addition, the benefits of using these medicines in the treatment of obesity are considered limited.
  • Other obesity treatment options are available. Contact your doctor to discuss which treatment would be suitable for you.
  • If you have other questions or concerns about amfepramone medicines, speak to your doctor or pharmacist.

Information for healthcare professionals

  • EMA is recommending the withdrawal of the EU marketing authorisations for amfepramone medicines for the treatment of obesity.
  • A review of available data has found that amfepramone medicines continue to be used outside the current risk minimisation measures included in the product information.
  • Inappropriate use may increase the risk of serious adverse effects, including cardiovascular disease, pulmonary arterial hypertension, dependency and psychiatric disorders, as well as harmful effects if used during pregnancy.
  • A review of available data also indicates that the efficacy of amfepramone in the treatment of obesity is limited.
  • Healthcare professionals should advise patients about other treatment options.

A direct healthcare professional communication (DHPC) will be sent in due course to healthcare professionals prescribing or dispensing the medicine and published on a dedicated page on the EMA website.

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