Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 April 2017

7 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

Agenda - PRAC draft agenda of meeting 3-6 April 2017

Safety signal evaluation

Uptravi (selexipag)
Summary of PRAC recommendation

Ongoing referrals

Procedure	Status	Update
Article 31 referral: Gadolinium-containing contrast agents	PRAC recommendation issued in March 2017	Following the PRAC's March 2017 recommendation, some of the marketing authorisation holders concerned by this referral procedure have requested a re-examination. Upon receipt of the grounds for their requests, the PRAC will start a re-examination, which is expected to conclude in July 2017.
Article-31 referral: Paracetamol-modified release	Under evaluation	PRAC continued its assessment
Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions	Under evaluation	PRAC continued its assessment
Article-31 referral: Factor VIII	Under evaluation	PRAC continued its assessment
Article-31 referral: Retinoid-containing medicinal products	Under evaluation	PRAC continued its assessment
Article-31 referral: Systemic and inhaled quinolone and fluoroquinolone antibiotics	Under evaluation	PRAC continued its assessment
Article-31 referral: Valproate and related substances	Under evaluation	PRAC continued its assessment