Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018

Immediate measures agreed for Zinbryta and Xofigo while reviews are ongoing; public hearing decided for quinolone and fluoroquinolone antibiotics

Contraindication for prostate cancer medicine Xofigo while review is ongoing

At its March meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, due to preliminary clinical trial results showing an increased risk of death and fractures with this combination.

The recommendation is being sent to the European Commission for a legally binding decision. This is a temporary measure until the ongoing in-depth review of the benefits and risks of Xofigo is complete.

More information is available below.

Immediate suspension and recall of multiple sclerosis medicine Zinbryta

On 2 March, the PRAC started an urgent review of the multiple sclerosis medicine Zinbryta (daclizumab beta). At its meeting this week, it recommended the immediate suspension and recall of the medicine. This follows 12 reports worldwide of serious inflammatory brain disorders, including encephalitis and meningoencephalitis.

This recommendation to suspend Zinbryta and recall the product is being sent to the European Commission for a legally binding decision. In parallel, the European Medicines Agency (EMA) will continue its in-depth review and make public the final outcome.

More information is available below.

Public hearing to be organised for quinolone and fluoroquinolone antibiotics

The PRAC decided to organise a public hearing as part of its review of quinolone and fluoroquinolone antibiotics, to listen directly to the experience of interested parties with these medicines, so this can be taken into account in the Committee’s recommendation.

In February 2017 the PRAC started a review of oral, injectable and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of rare serious side effects mainly affecting muscles, joints and the nervous system, some of which may be of long duration. As the review progressed, EMA observed an increased public interest in the safety of these medicines. The PRAC, taking into account this increased interest, considered it would be useful to hold a hearing to better understand the public’s views on the risks associated with these antibiotics and the feasibility of certain measures to optimise their safe use.

This public hearing will take place during the Committee’s meeting of June 2018. Further information, including a summary of the safety concerns, a list of specific questions on which information from the public is sought, as well as practical information on how to participate and an application form will be published soon on the Agency’s website.

It is the second time that the PRAC will hold a public hearing during a safety review of a medicine, following the first public hearing held in September 2017 to inform the review of valproate - a medicine that treats epilepsy, bipolar disorder and migraine.


Agenda - PRAC draft agenda of meeting 5-8 March 2018


Start of referral


Article-20 procedure: Zinbryta


PRAC list of questions

Timetable for the procedure

Referral notification


Temporary recommendation by PRAC


Article-20 procedure: Xofigo


Summary of temporary recommendation


Ongoing referral

Article-20 procedure: EsmyaUnder evaluationPRAC adopted a list of outstanding issues for the marketing authorisation holder.

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