21 March 2019 DDL_fluoroquinolones_March-2019
Fluoroquinolone antibiotics: ciprofloxacin, levofloxacin,
moxifloxacin, ofloxacin
New restrictions and precautions due to very rare reports of disabling and
potentially long-lasting or irreversible side effects
• Disabling, long-lasting or potentially irreversible adverse reactions affecting
musculoskeletal (including tendonitis and tendon rupture) and nervous systems have
been reported with fluoroquinolone antibiotics – see Drug Safety Update for more
information
• Prescribers and dispensers of fluoroquinolones should 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 – see MHRA sheet to discuss measures with patients
• Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or
inflammation in patients and the affected limb or limbs appropriately treated (for
example with immobilisation)
Fluoroquinolones should not be prescribed for:
• non-severe or self-limiting infections, or non-bacterial conditions
• mild to moderate infections (such as in acute exacerbation of chronic bronchitis
and chronic obstructive pulmonary disease) unless other antibiotics that are
commonly recommended for these infections are considered inappropriate*
• uncomplicated cystitis (for which ciprofloxacin or levofloxacin were previously
authorised) unless other antibiotics that are commonly recommended are
considered inappropriate*
*For example, when first-line antibiotics are unsuitable due to resistance, contraindications, or intolerance,
or if first-line treatments have failed.
• Avoid coadministration with corticosteroids since this could exacerbate
fluoroquinolone-induced tendinitis and tendon rupture
• Avoid use in patients who have previously had serious adverse reactions with a
quinolone or fluoroquinolone antibiotic
• Prescribe with special caution in 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
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Trigger for the advice on fluoroquinolones
An EU review of the safety fluoroquinolone and quinolone antibiotics was triggered by reports of
disabling and potentially long-lasting, irreversible side effects mainly affecting the musculoskeletal and
nervous systems. See Drug Safety Update for characteristics of reactions reported.
The review identified 286 cases of serious adverse reactions reported as disabling and lasting for 30
days or more, without any alternative explanations, from across the EU over a 21-year period.
Although cumulative fluoroquinolone patient exposure data are not available for this time period, it is
estimated that more than 300 million daily doses of fluoroquinolone antibiotics are dispensed every
year in the EU.
Although relatively few cases have been reported, under-reporting is likely. Due to the seriousness of
these reactions sometimes reported in previously healthy people, any decision to prescribe a
fluoroquinolone should be taken after a careful assessment of the benefits and risks in each case.
If fluoroquinolones are to be used, prescribers should ensure they consult the Summary of Product
Characteristics and national guidance, and inform patients of the actions they should take at the first
signs of a serious adverse reaction.
Report any suspected adverse event reactions to fluoroquinolones to the Yellow Card Scheme online
(https://yellowcard.mhra.gov.uk/) or the Yellow Card App (download via iTunes Yellow Card for iOS
devices or via PlayStore Yellow Card for Android devices).
Nalidixic acid
The quinolone nalidixic acid was authorised for urinary tract infections, which is no longer a permitted
indication. Therefore, the licence for nalidixic acid has been cancelled.
Yours sincerely,
Dr June Raine
Director, Vigilance and Risk Management of Medicines (VRMM) Division,
MHRA
[email protected]
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