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|
|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|
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- Acronyms and abbreviations used in PRAC minutes (2014-07-22)