The European Medicines Agency (EMA) is to hold a public hearing on personal experiences with quinolone and fluoroquinolone antibiotics. The hearing will form part of the review of oral, injectable and inhaled quinolone and fluoroquinolone antibiotics which is evaluating the persistence of serious side effects.
The review was initiated in February 2017. The EMA says, as the review progressed, it observed increased public interest in the safety of these medicines and taking into account this increased interest, the agency decided it would be useful to hold a hearing “to better understand the public’s views on the risks associated with these antibiotics and the feasibility of certain measures to optimise their safe use”.
The public hearing will take place during the meeting of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in June 2018. Further information, including a summary of the safety concerns, a list of specific questions on which information from the public is sought, and an application form will be published soon on the EMA’s website.
This is only the second time that the EMA has held a public hearing during a safety review of a medicine. The first hearing, in 2017, was held as part of the review of the safety of valproate in pregnancy.