EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of Uptravi (selexipag), following the deaths of 5 patients taking the medicine in France. Based on a preliminary review of available data, EMA advises that Uptravi may continue to be used, but use must be in line with the current prescribing information.
The PRAC will further explore all available data. Once the review is completed, final conclusions will be published.
EMA reviewing safety of Uptravi for pulmonary arterial hypertension (updated)