The European Medicines Agency (EMA) has opened registration for its next public hearing which will take place on 13 June 2018 at EMA’s premises. The public hearing will give a voice to patients, doctors, nurses, pharmacists, researchers and everyone else who wants to share experience with quinolones and fluoroquinolones, a class of antibiotics widely prescribed in the European Union (EU).
The public hearing is part of a review being carried out by EMA’s safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), that is investigating reports of serious persistent side effects mainly affecting muscles, joints and the nervous system. Some of these side effects have been reported in patients with infections that were not severe and could have been treated with other antibiotics.
The PRAC would like to hear from the public what it thinks about the risks associated with these antibiotics. It also wants to explore whether further measures could ensure that these antibiotics are used as safely as possible.
“The public hearing provides citizens with the opportunity to contribute to this review. Their experiences and views will complement the available scientific evidence and enrich PRAC’s deliberations,” said Guido Rasi, EMA’s Executive Director. “Public hearings underline our commitment to include patients and healthcare professionals in our decision-making.”
Those interested in participating in the public hearing, either as a speaker or an observer should submit an application form to EMA no later than 30 April 2018. EMA will review the applications. Speakers will need to address the questions from the PRAC and will be selected based on their experience with quinolones and fluoroquinolones. The Agency also seeks to achieve a wide representation of all groups of stakeholders across the EU.