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Quinolones - restrictions and precautions due to very rare reports of disabling and potentially long-lasting or irreversible side effects

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

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Systemic and inhaled fluoroquinolones are associated with a risk of serious, disabling, long-lasting and potentially irreversible adverse reactions, estimated to occur in at least between 1 and 10 people in every 10,000 who take a fluoroquinolone (1):

  • may affect multiple body systems and include musculoskeletal, nervous, psychiatric and sensory reactions
  • adverse reactions have been reported in patients irrespective of their age and potential risk factors.
  • patients have reported that experiencing long-lasting or disabling reactions can affect their mental health, particularly when they perceive healthcare professionals fail to adequately acknowledge the reactions or the possibility that they are associated with a fluoroquinolone
  • tendon damage can occur within 48 hours of commencing treatment, or the effects can be delayed for several months and become apparent after stopping treatment
  • are no proven drug treatments for these side effects
    • however, it is important that fluoroquinolones are stopped immediately at the first signs of a musculoskeletal, neurological or psychiatric side effect, such as those described above to avoid further exposure, which could potentially worsen adverse reactions
    • these symptoms should be appropriately investigated

  • Advice for healthcare professionals (1):

  • systemic (by mouth, injection, or inhalation) fluoroquinolones can cause long-lasting (up to months or years), disabling and potentially irreversible side effects, sometimes affecting multiple body systems and senses
  • the UK indications for systemic fluoroquinolones have been updated so they must only be used in situations when other antibiotics, that are commonly recommended for the infection, are inappropriate
  • situations in which other antibiotics are considered to be inappropriate and where a fluoroquinolone may be indicated are where:
    • there is resistance to other first-line antibiotics recommended for the infection
    • other first-line antibiotics are contraindicated in an individual patient
    • other first-line antibiotics have caused side effects in the patient requiring treatment to be stopped
    • treatment with other first-line antibiotics has failed
  • this goes further than previous measures which set out that fluoroquinolones should not be prescribed for non-severe or self-limiting infections, or non-bacterial conditions, for example non-bacterial (chronic) prostatitis. These measures are still in place
  • as a reminder, patients should be advised to stop fluoroquinolone treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects, and to contact their doctor immediately
  • refer to MHRA’s sheet for patients for further advice
  • remain alert to the risk of suicidal thoughts and behaviours with use of fluoroquinolone antibiotics - see https://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-suicidal-thoughts-and-behaviour
  • advice published in August 2023 issue states:
    • avoid fluoroquinolone use in patients who have previously had serious adverse reactions with a quinolone antibiotic (for example, nalidixic acid) or a fluoroquinolone antibiotic
    • prescribe fluoroquinolones with special caution for people older than 60 years and for those with renal impairment or solid-organ transplants, because they are at a higher risk of tendon injury
    • avoid coadministration of a corticosteroid with a fluoroquinolone since this could exacerbate fluoroquinolone-induced tendinitis and tendon rupture

A study showed no increased risk of aortic aneurysm and aortic dissection (AA/AD) associated with fluoroquinolone (FQ) use (2).

Reference:

  • MHRA - Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate. Drug Safety Update volume 17, issue 6: January 2024: 2.
  • Hung K et al. Lack of association between fluoroquinolone and aortic aneurysm or dissection, European Heart Journal, 2023;, ehad627, https://doi.org/10.1093/eurheartj/ehad627

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