Quinolones safety review: 55 requests to speak at EMA hearing


  • Dawn O'Shea
  • International Medical News
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The European Medicines Agency (EMA) has received 55 requests from citizens to address its upcoming public hearing on quinolones and fluoroquinolones.

A total of 115 patients, doctors, nurses, pharmacists, academics, and representatives of EU associations have registered to attend the event, which will take place on 13 June in London. Sixty registrants expressed an interest to participate as observers. Of the 55 attendees who requested to speak at the hearing, 23 were selected from 11 European Union (EU) Member States to share their views at the event. Individuals who requested to speak but who could not be allocated a slot will have their written contributions transmitted to the scientific committee, all of which will be taken into account during the process and published on the EMA website.

The public hearing is part of a review being carried out by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) to investigate the persistence of serious side effects with quinolones and fluoroquinolones, particularly affecting the musculoskeletal and nervous system. The review was initiated on 9 February 2017 at the request of the German medicines authority (BfArM).

The hearing will be broadcast live on the EMA website from 13:00 to 18:00 (UK time) on 13 June.