Obesity is a global medical issue and one with far-reaching impacts on health and quality of life. As such, many pharmaceutical companies have devoted efforts to research medicines which prevent or reduce obesity and/or weight gain.  There are currently two pharmaceutical avenues in the treatment and/or prevention of obesity: Drugs which act in the gut and inhibit fat absorption, and drugs which act at the CNS level to suppress appetite. In past years, many drugs were developed to suppress appetites. However, RWE studies underlined the risk of the latter group, as they were often administered for several months and caused severe adverse reactions.

Recently, the EMA safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorizations 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 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 minimize 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 PRAC recommendation will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for its consideration.

You can read more at the EMA website.

References

  1. EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines. (2022, October 28). European Medicines Agency. https://www.ema.europa.eu/en/news/ema-confirms-recommendation-withdraw-marketing-authorisations-amfepramone-medicines

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