EMA Reviews Amfepramone Medicines

The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.

The European Medicines Agency (EMA) announced that concerns regarding products containing amfepramone have been raised after its Pharmacovigilance Risk Assessment Committee (PRAC)

reviewed the periodic safety update report for amfepramone. The agency stated in a press release that these concerns—which include heart problems, high blood pressure in the lungs, longer than recommended use, using more than the recommended dose, and use during pregnancy—require further evaluation. The announcement came after PRAC’s February meeting held Feb. 8–11, 2021.

In some European Union countries, medicines containing amfepramone are used to treat obesity in patients that have not been able to reduce their weight with other methods. Because of the safety concerns the Romanian medicines agency has requested a review of these products.

EMA also announced in the press release that PRAC concluded its review of reports of acute kidney injury in patients with COVID-19 treated with Veklury (remdesivir) and found “there is no evidence indicating that the reported kidney problems are associated with the use of Veklury.” The agency said it will continue to monitor the risk of kidney injury. PRAC also is reviewing a safety signal raised by the Italian Medicines Agency regarding 11 cases of sinus bradycardia in patients treated with Veklury.