Quinolone- and fluoroquinolone-containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics

On 15 November 2018, EMA finalised a review of serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on fluoroquinolone and quinolone antibiotics in June 2018.

EMA’s human medicines committee (CHMP) endorsed the recommendations of EMA’s safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended.

The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system.

Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:

  • to treat infections that might get better without treatment or are not severe (such as throat infections);
  • to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
  • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
  • to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.

Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.

The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 14 February 2019 for Quinsair and on 11 March 2019 for other quinolone and fluoroquinolone antibiotics given by mouth and by injection, which is applicable in all EU countries. National authorities will enforce this decision for the fluoroquinolone and quinolone medicines authorised in their countries and they will also take other appropriate measures to promote the correct use of these antibiotics.

Key facts

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
Associated names
Quinsair
Class
Quinolones and fluoroquinolones
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1452
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union 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
PRAC recommendation date
04/10/2018
CHMP opinion/CMDh position date
15/11/2018
EC decision date
11/03/2019
Outcome
Risk minimisation measures

Public hearing

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) held a public hearing on this topic on 13 June 2018 at the Agency's premises in London:

bg - balgarski,

cs - čeština,

da - dansk,

de - Deutsch,

el - ελληνικά,

es - español,

et - eesti keel,

lt - lietuvių kalba,

fr - français,

hr - Hrvatski,

hu - magyar,

it - italiano,

lv - latviešu valoda,

mt - Malti,

nl - Dutch,

pl - polski,

pt - português,

ro - romana,

sk - slovenčina,

sl - slovenščina,

fi - suomi,

sv - svenska.

 

The hearing was broadcast live on 13 June from 13:00 - 18:00 (UK time).

The video recording is available.

Speakers addressed the questions from the PRAC about the use of quinolones and fluoroquinolones:

More information

EMA selected speakers based on their experience with these medicines and how they plan to address the PRAC questions, whilst aiming to achieve a wide representation of stakeholders across the EU. The application deadline to participate in person was 30 April 2018.

EMA published detailed guidance on how to participate in a public hearing, including what to expect, how to register and how EMA selects speakers:

public_hearings_guidance_thumbnail

PDF icon Public hearings - guidance for participants

The guidance describes the process and practical arrangements, including how to participate as a speaker or an observer.

EMA has also made an information video.

For more information on public hearings at EMA, see Public hearings.

The hearing will take place at the June PRAC meeting.

For additional information not available in the guidance, please email publichearings@ema.europa.eu.

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

European Commission final decision

  • List item

    Quinolone and fluoroquinolone Article-31 referral - Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics (PDF/140.61 KB)


    First published: 16/11/2018
    Last updated: 19/03/2019
    EMA/175398/2019

  • List item

    Quinolone and fluoroquinolone Article-31 referral - Annex IV (PDF/16.71 KB)


    First published: 19/03/2019

  • List item

    Quinolone and fluoroquinolone Article-31 referral - Annex II (PDF/176.91 KB)


    First published: 19/03/2019

  • List item

    Quinolone and fluoroquinolone Article-31 referral - Assessment report (PDF/1.06 MB)

    Adopted

    First published: 19/03/2019
    EMA/818158/2018

  • List item

    Quinolone and fluoroquinolone Article-31 referral - Annex III (PDF/287.92 KB)


    First published: 19/03/2019

  • List item

    Quinolone and fluoroquinolone Article-31 referral - Annex I (PDF/3.37 MB)


    First published: 13/02/2017
    Last updated: 19/03/2019

  • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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