BRIEF—EMA's PRAC held public hearing on quinolone and fluoroquinolone antibiotics

15 June 2018

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

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.

Ongoing referrals

Procedure

Status

Update

Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal products

Under evaluation

PRAC held a public hearing and continued its assessment

Article-20 procedure: Xofigo

Under evaluation

PRAC adopted a list of outstanding issues to be addressed by the marketing authorisation holders

Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC continued its assessment