Quinolone- and fluoroquinolone-containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
Recommendation provided by Pharmacovigilance Risk Assessment Committee

Overview

Fluoroquinolone and quinolone antibiotics: PRAC recommends restrictions on use

New restrictions follow review of disabling and potentially long-lasting side effects

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics (used by mouth, injection or inhalation) following a review of disabling and potentially long-lasting side effects reported with these medicines. 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.

Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons and bones and the nervous system.   

Following its evaluation of these side effects, the PRAC has recommended that some medicines, including all those that contain a quinolone antibiotic, should be removed from the market. This is because they are authorised only for infections that should no longer be treated with this class of antibiotics.

The PRAC recommended that the remaining fluoroquinolone antibiotics should:

  • not be used
    • to treat infections that might get better without treatment or are not severe (such as throat infections);
    • for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
    • to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic;
    • to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used;
  • be used with caution especially for the elderly, patients with kidney problems, patients who have had an organ transplantation or those who are being treated with a systemic corticosteroid. These patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.

The PRAC also recommended that healthcare professionals should advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).

Prescribing information of individual fluoroquinolone antibiotics will be updated to reflect the restricted use.

The PRAC recommendations will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.

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
Recommendation provided by Pharmacovigilance Risk Assessment Committee
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
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

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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