Public hearing on quinolones and fluoroquinolones at EMA

date: 26/04/2018

The European Medicines Agency (EMA) is reviewing the quinolone and fluoroquinolone antibiotics. At its March 2018 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) decided that it would be of benefit to engage the wider EU public in this review.

Quinolones and fluoroquinolones are a class of antibiotics which are widely prescribed in the European Union (EU) and are important for treating serious, life threatening bacterial infections.

EMA is reviewing these medicines due to 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 review was started after the German medicines authority (BfArM) notified EMA of reports of long-lasting side effects in their national safety database and the published literature.

The review of quinolones and fluoroquinolones is being carried out by EMA’s Safety Committee.

At its March 2018 meeting, the PRAC decided that it would be of benefit to engage the wider EU public in this review. In particular, the PRAC would like to hear the public’s view on acceptability of risks associated with quinolones and fluoroquinolones in both mild and severe infections, and to explore what further measures could be taken to ensure that these antibiotics are used as safely as possible.

The public hearing will be held on 13 June 2018 at the EMA offices in London and it will focus on the questions outlined below. Information about public hearings, including full details on how this hearing will be conducted and how interested individuals can participate, is available on EMA’s webpage for public hearings.

After the public hearing, the PRAC will continue its review according to the published timetable. Once the assessment is finalised, the PRAC will publish a report on the safety of quinolones and fluoroquinolones which will set out its conclusions and will clearly explain how the information gathered during the public hearing has informed the Committee’s recommendations.

Questions for the public

Within the scope of this review and based on your experience with quinolone and fluoroquinolone treatment :

  1. What is your view on the role of quinolones and fluoroquinolones in the treatment of infections ?
  2. What is your view of the risks associated with quinolone and fluoroquinolone use ?
  3. In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones ?

In Belgium, medicinal products containing quinolones and fluoroquinolones are available under the following commercial names :

  • Ciprofloxacin containing medicinal products : Ciprofloxacine EG, Ciprofloxacine Fresenius Kabi, Ciprofloxacine Mylan, Ciprofloxacine Sandoz, Ciprofloxacine Teva, Ciproxine.
  • Levofloxacin containing medicinal products : Levofloxacine EG, Levofloxacine Fresenius Kabi, Levofloxacine Mylan, Levofloxacine Sandoz, Levofloxacine Teva, Tavanic.
  • Moxifloxacin containing medicinal products : Avelox, Moxifloxacin Apotex, Moxifloxacin EG, Moxifloxacine Fresenius Kabi, Moxifloxacine Mylan, Moxifloxacine Teva, Moxifloxacine Sandoz.
  • Norfloxacin containing medicinal products : Norfloxacine EG.
  • Ofloxacin containing medicinal products : Ofloxacine EG, Ofloxacine Mylan, Tarivid.

More information is available on the EMA website.

Last updated on 26/04/2018