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 |
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 |
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