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Agenzia Italiana del Farmaco
EMA recommends withdrawal of marketing authorisation for amfepramone medicines - EMA recommends withdrawal of marketing authorisation for amfepramone medicines
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 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.
| Update as of 3 August 2022: The marketing authorisation holders of amfepramone medicines have requested a re-examination of EMA’s June 2022 recommendation to withdraw EU marketing authorisation for these medicines. Upon receipt of the grounds of the request, the Agency will re-examine its recommendation and issue a final recommendation. |
| Update as of 11 november 2022: On 27 October 2022, 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 CMDh agreed with the PRAC recommendation and adopted its position by majority on 10 November 2022. As the CMDh position was adopted by majority vote, it will now be sent to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. . |
Published on: 13 June 2022
