European Withdrawal of Amfepramone – End of an Era!

On Jun 10, 2020, the European Medicines Agency (EMA) recommended the withdrawal of amfepramone from the European market

This agent, belonging to the group of amphetamine-like stimulants, was authorised in Denmark, Germany, and Romania under the trade names Amfepramone Hormosan, Regenon, and Tenuate for weight reduction. 

Due to an increased risk of significant side effects including cardiovascular disease, pulmonary arterial hypertension, dependency and psychiatric disorders, as well as harmful effects if used during pregnancy, use of amfepramone was limited to no longer than three months. 

However, as the EMA review of amfepramone use revealed, 

“…amfepramone medicines continue to be used outside the current risk minimisation measures included in the product information.”

As the EMA could not see any further measures that would be sufficiently effective to minimise the risk of side effects, it 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.

Notably, EMA also stated that other treatment options for obesity are available and that health professionals should inform patients about these options. 

Thus, it appears that at least in Europe, the era of amphetamine-like sympathomimetic medications for weight loss is finally coming to an end. 

No doubt, many health care professionals and patients, who may have relied on amfepramone in the past, will state that, despite possible risks, this medication at least was affordable to the many patient desperate for obesity treatment.

Indeed, the vast majority of patients seeking anti-obesity medications, who may have swallowed the rather low cost of amfepramone (pun intended), may well baulk at the cost of the newer class of GLP-1 analogues (liraglutide, semaglutide), despite being deemed safer and more effective. 

This issue will need to be addressed by fair pricing policies and the hope that the daily cost of liragutide will drop considerably once the more effective once-weekly semaglutide enters the market, thus providing an affordable alternative to patients, who have previously relied on amfepramone. 

Ultimately, I see no alternative than to include reimbursement for safe and effective anti-obesity medications in health plans, thus making these treatments available to more than just the upper 1% who can afford to pay out-of-pocket. 

Berlin, D