Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2018

News 15/06/2018

PRAC held public hearing on quinolone and fluoroquinolone antibiotics

At its June meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed two ongoing safety reviews, as shown in the published agenda.

As part of a safety review investigating the persistence of serious side effects with quinolone and fluoroquinolone antibiotics mainly affecting muscles, joints and the nervous system, the PRAC held a public hearing to listen to the views and experiences of European citizens. The aim of the hearing was to explore which further measures could ensure that these antibiotics are used as safely as possible. The insights from participants will complement the available scientific evidence, will enrich the PRAC's deliberations and will be used to finalise its assessment. A summary report will be published on EMA's website shortly.

Ongoing safety reviews are shown in the table below. The Committee did not start or conclude a referral.

Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting at the beginning of July.


PDF icon Agenda - PRAC draft agenda of meeting 11-14 June 2018

Ongoing referrals

Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationPRAC held a public hearing and continued its assessment
Article-20 procedure: XofigoUnder evaluationPRAC adopted a list of outstanding issues to be addressed by the marketing authorisation holders
Article-31 procedure: Methotrexate containing medicinal productsUnder evaluationPRAC continued its assessment

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