EMA Upholds Recommendation For Withdrawing Marketing Authorization for Amfepramone Obesity Medicines

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), the regulatory agency’s committee responsible for assessing risk in medicines for human use, confirmed its decision to withdraw marking approval for amfepramone obesity medicines.

The recommendation came after the review of data from various studies, demonstrating an increased risk of serious side effects occurring with these treatments. With the confirmation of this recommendation on October 28, the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) will consider PRAC’s recommendation.

Related Article: FDA Announces Two Product Recalls Over Concerns of Particulates and Impurities

The Evidence For Withdrawing Marketing Authorizations

Amfepramone is a stimulant drug used as an appetite suppressant for the short-term management of obesity. Though studies demonstrate that patients taking these drugs experience 5-10% weight loss, they also experience a notable amount of concerning side effects. These include pulmonary arterial hypertension (high blood pressure in the lungs) and dependency. 

Due to concern over these side effects, in June of this year, PRAC reviewed the safety of amfepramone obesity medicines. On top of the aforementioned side effects, the committee found that patients with a history of heart disease or psychiatric disorders used these treatments, thereby increasing the risk of their prior conditions. PRAC also found the drug’s use in pregnant patients, posing a risk to the unborn child. 

As a result, PRAC recommended the removal of amfepramone obesity medicines from the market in the European Union. 

Despite their findings, the companies that market these medicines requested a reexamination of PRAC’s findings. However, the reexamination only confirmed PRAC’s prior position. In a press release published on October 28, the EMA detailed its consideration of all the available information. This info included two studies on the use of amfepramone medicines in Germany and in Denmark as well as advice from endocrinologists, cardiologists, and a patient representative. 

PRAC upheld their recommendation, stating that the use of amfepramone obesity medicines does not outweigh their risks. 

Going forward, the CMDh will consider PRAC’s findings. Should they agree with the safety committee, the European Commission will make a final decision on withdrawing marketing authorizations of amfepramone obesity medicines from the European market. 

Author

Max Heirich