Other safety alerts
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| European Union: EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines |
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The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has 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 European Union.
The PRAC recommendation will now be sent to EMA’s Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for its consideration.
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.
The review has been carried out by the PRAC. Following a re-examination requested by the marketing authorisation holders, the PRAC subsequently confirmed its conclusions for amfepramone-containing medicines. Because these medicines are all authorised at national level, the PRAC recommendations will now be sent to the CMDh, which will adopt a position.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-confirms-recommendation-withdraw-marketing-authorisations-amfepramone-medicines
In Hong Kong, there is one registered pharmaceutical product containing amfepramone, namely Dipropion Capsules 75mg (HK-64796). The product is registered by Jean-Marie Pharmacal Co Ltd. It is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to amfepramone. Related news was previously issued by the EMA, and was posted on the Drug Office website on 11 Jun 2022. As previously reported, since the PRAC recommendation will now be sent to the CMDh for consideration, the DH will remain vigilant on safety update of the drug issued by EMA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, October 29, 2022
Issued at HKT 13:30
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