Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2017

News 05/05/2017

PRAC concludes review of medicines containing factor VIII

At its May meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of factor VIII medicines to evaluate the risk of developing inhibitors in patients with haemophilia A who have not previously been treated with these medicines.

Factor VIII is needed for blood to clot normally and is lacking in patients with haemophilia A. Factor VIII products replace the missing factor VIII and help control bleeding. However the body may develop inhibitors as a reaction to these medicines, particularly in patients starting treatment for the first time. This can block the effect of these medicines, so bleeding is no longer controlled.

The review was started following publication of a study which concluded that inhibitors develop more frequently in patients receiving recombinant factor VIII medicines than in those receiving plasma-derived factor VIII medicines. The PRAC concluded that there is no clear and consistent evidence of a difference in inhibitor development between the two classes of factor VIII medicines.

More information is available below.


PDF icon Agenda - PRAC draft agenda of meeting 2-5 May 2017

Recommendation by PRAC

Factor VIII

Article-31 referral: Factor VIII

PDF icon Summary of recommendation

Ongoing referrals

Article 31 referral: Gadolinium-containing contrast agentsPRAC recommendation issued in March 2017Following 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 releaseUnder evaluationPRAC continued its assessment
Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactionsUnder evaluationPRAC continued its assessment
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Systemic and inhaled quinolone and fluoroquinolone antibioticsUnder evaluationPRAC continued its assessment
Article-31 referral: Valproate and related substancesUnder evaluationPRAC continued its assessment

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