Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August-1 September 2017

  • Email
  • Help

News

01/09/2017

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August-1 September 2017

PRAC concludes two referrals; PRAC approves the list of participants and the agenda for the public hearing on valproate

PRAC recommends modified-release paracetamol to be removed from the market

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that modified- or prolonged-release paracetamol products (designed to release paracetamol slowly over a longer period than the usual immediate-release products) should be removed from the market. The decision was taken in view of the difficulties of managing overdose in patients, due to the complex way these medicines release paracetamol into the body.

After evaluating published studies and consulting experts, the Committee confirmed that when used in the approved way, modified-release paracetamol tablets have acceptable benefits and risks. However, experience has shown that in overdose, because of the way the paracetamol in modified-release products is released in the body, the usual treatment procedures developed for immediate-release products are not appropriate. The PRAC therefore recommended the suspension of the marketing authorisations of these medicines.

More information is available below.

PRAC confirms there is no consistent evidence of a difference in risk between plasma-derived and recombinant factor VIII medicines

Following a re-examination procedure, the PRAC has confirmed its previous conclusion of May 2017 that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines used for treating haemophilia A: those derived from plasma and those made by recombinant DNA technology.

Due to the different characteristics of individual products within the two classes, the PRAC reaffirmed that the risk of inhibitor development should be evaluated individually for each medicine, regardless of class. The risk for each product will continue to be assessed as more evidence becomes available.

More information is available below.

PRAC approves the list of participants and the agenda for the public hearing on valproate

PRAC approved the list of participants and the agenda for the public hearing on valproate, which will take place on 26 September 2017. A total of 79 citizens applied to participate as speakers or observers. While speaker slots are limited, applicants will be all invited to attend the hearing at the Agency's premises in London. EMA will get in touch with them within the next two weeks to confirm their availability and whether a slot to speak can be offered. For those who cannot attend in person, the hearing will be broadcast live on EMA’s website. The agenda and list of participants will be published prior to the event.

Agenda

 
Agenda - PRAC draft agenda of meeting 29 August-1 September 2017

 

Recommendations by PRAC

Factor VIII

Article-31 referral: Factor VIII

 

Summary of PRAC recommendation

 

Paracetamol-modified release

Article-31 referral: Paracetamol-modified release

 

Summary of PRAC recommendation

 

Ongoing referrals

ProcedureStatusUpdate
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Valproate and related substancesUnder evaluationPRAC continued its assessment. PRAC approved the list of participants and agenda for the public hearing that will take place on 26 September.
Article-20 referral: ZinbrytaUnder evaluationPRAC issued provisional measures in July to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.

 

How helpful is this page?

Average rating:

 Based on 9 ratings

Add your rating:

See all ratings
2 ratings
0 ratings
0 ratings
2 ratings
5 ratings
    

Tell us more

Related content

Related documents

Contact point:

EMA press office
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu
Follow us on Twitter @EMA_News