Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2017
NewsHumanPharmacovigilance
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.
Agenda
Recommendation by PRAC
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: 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 |