Quinolone- and fluoroquinolone-containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

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

EMA has reviewed 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) has 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 will now be forwarded to the European Commission, which will issue a final legally binding decision 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
Opinion provided by Committee for Medicinal Products for Human Use
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
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 iconPublic 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

Opinion provided by Committee for Medicinal Products for Human Use

Document description

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the CHMP or 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 or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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