EMA to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics
Review to focus on long-lasting effects mainly affecting musculoskeletal and nervous systems
The European Medicines Agency (EMA) is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. These side effects are of particular importance when the medicines are used for less severe infections.
The review is at the request of the German medicines authority (BfArM) following reports of long-lasting side effects in the national safety database and the published literature. There has been no previous EU-wide review specifically focusing on the persistence of the side effects, but the side effects themselves are known and covered in the EU prescribing information for these medicines.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will now evaluate all available data and determine whether there is a need to introduce new measures to minimise these risks or modify how the medicines are used.
Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections. Healthcare professionals using these medicines should continue to follow the official prescribing information.
Patients who have any questions about their treatment should speak to their doctor.
- More about the medicines
Quinolones and fluoroquinolones are a class of broad spectrum antibiotics that are active against so‑called Gram-negative and Gram-positive bacteria.
The review covers the following medicines: cinoxacin, ciprofloxacin, enoxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin.
The review concerns only inhaled medicines and medicines given systemically (by mouth or injection). Topical medicines, such as those applied directly to the skin, eyes or ears, are not included.
- More about the procedure
The review of quinolone and fluoroquinolone antibiotics was initiated on 9 February 2017 at the request of German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.
The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will issue recommendations. The PRAC recommendations will then be sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
|Name||Language||First published||Last updated|
|Quinolone and fluoroquinolone Article-31 referral - Review started||(English only)||2017-02-10|
About this medicine
|Approved name||Quinolone- and fluoroquinolone-containing medicinal products|
|International non-proprietary name (INN) or common name|
nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin
|Class||Quinolones and fluroquinolones|
About this procedure
|Current status||Procedure started|
|Type||Article 31 referrals|
This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
|Decision making model||PRAC-CHMP-EC|
|Authorisation model||Centrally and nationally authorised products (mixed)|
Key dates and outcomes
|Procedure start date||09/02/2017|
|Name||Language||First published||Last updated|
|Quinolone and fluoroquinolone Article-31 referral - Review started||EN = English||2017-02-10|
|Quinolone and fluoroquinolone Article-31 referral - Notification||EN = English||2017-02-10|
|Quinolone and fluoroquinolone Article-31 referral - PRAC list of questions||EN = English||2017-02-10|
|Quinolone and fluoroquinolone Article-31 referral - Annex I||EN = English||2017-02-13|
|Quinolone and fluoroquinolone Article-31 referral - Timetable for the procedure||EN = English||2017-02-10|
More documentsThere are currently no documents published in this section
- Annex I - List of the medicines affected by the referral
- Annex II - Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
- Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
- Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
- Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
- Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
- PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
- PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
- PRAC / CHMP / CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated