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Fluoroquinolone antibiotics and suicidal thoughts and behaviour

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

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Fluoroquinolone antibiotics and suicidal thoughts and behaviour

The Medicines and Healthcare products Regulation Agency (MHRA) state that (1):

  • healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of psychiatric reactions, including depression and psychotic reactions, which may potentially lead to thoughts of suicide or suicide attempts
  • healthcare professionals are also reminded to advise patients to be alert to these risks

Advice for healthcare professionals (1):

  • advise patients to carefully read the advice in the Patient Information Leaflet about possible psychiatric reactions, and to seek medical advice if they experience these symptoms
  • when prescribing a fluoroquinolone, advise patients to be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment
  • note that fluoroquinolones can exacerbate existing psychiatric symptoms
  • advise patients to seek medical advice if they develop such thoughts or behaviours, and ensure that a suitable referral for treatment is made, if necessary
  • fluoroquinolones should be discontinued at the first signs of a serious adverse reaction, including new or worsening depression or psychosis
  • report suspected adverse drug reactions (ADRs) to the Yellow Card Scheme

Fluoroquinolone antibiotics - restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects (2)

Systemic and inhaled fluoroquinolones are associated with a risk of serious, disabling, long-lasting and potentially irreversible adverse reactions. These may affect different, sometimes multiple, body systems, and may include musculoskeletal, nervous, psychiatric, and sensory reactions. They have been reported in patients irrespective of their age and risk factors

  • fuoroquinolone treatment should be discontinued at the first signs of a serious adverse reaction, including tendon pain or inflammation
  • 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 (3)

  • Advice for healthcare professionals (2):

    • systemic (by mouth, injection, or inhalation) fluoroquinolones can very rarely cause long-lasting (up to months or years), disabling, and potentially irreversible side effects, sometimes affecting multiple systems, organ classes, and senses

    • advise patients to stop 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 for further advice - sheet for patients

    • do not prescribe fluoroquinolones:
      • for non-severe or self-limiting infections, or non-bacterial conditions
      • for some mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease; please refer to revised indications in the Summary of Product Characteristics) unless other antibiotics that are commonly recommended for these infections are considered inappropriate

    • ciprofloxacin or levofloxacin should no longer be prescribed for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate

    • avoid use in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic

    • prescribe 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 use of a corticosteroid with a fluoroquinolone since coadministration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture

Reference:

  • Drug Safety Update volume 17, issue 2: September 2023: 2.
  • Drug Safety Update volume 17, issue 1: August 2023: 1.
  • Drug Safety Update volume 17, issue 6: January 2024: 2.

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