Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 April 2017
PRAC concludes review of safety signal for Uptravi
At its April meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) completed the safety review of Uptravi (selexipag), which is used to treat pulmonary arterial hypertension, a life-threatening condition involving abnormally high blood pressure in the arteries of the lungs. The review was initiated following the deaths of five patients in France. The PRAC concluded that the data examined do not suggest an increase in mortality with Uptravi and the medicine can continue to be used by both new and existing patients according to the current prescribing information.
More information is available below.
|Agenda - PRAC draft agenda of meeting 3-6 April 2017|
Safety signal evaluation
|Summary of PRAC recommendation|