Other safety alerts
|
| |
| European Union: EMA recommends withdrawal of marketing authorisation for amfepramone medicines |
| |
European Medicines Agency (EMA) announces that the Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of European Union (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.
Information for healthcare professionals:
- EMA is recommending the withdrawal of the EU marketing authorisations for amfepramone-containing 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.
- There is limited efficacy of a short-term treatment as patients usually regain weight following cessation of treatment.
- Healthcare professionals should advise patients about other treatment options.
The PRAC recommendation will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/ema-recommends-withdrawal-marketing-authorisation-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. As 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, Jun 11, 2022
Issued at HKT 12:30
|
| |
|
