Indications of quinolone antibiotics restricted following EU-wide safety review

New restrictions and precautions for use have been implemented for quinolone antibiotics following very rare reports of disabling, long-lasting or potentially irreversible adverse reactions affecting the musculoskeletal and nervous systems.

Tendon damage (especially to the Achilles tendon but also other tendons) can occur within 48 hours of starting quinolone treatment. | GUSTOIMAGES/SCIENCE PHOTO LIBRARY
Tendon damage (especially to the Achilles tendon but also other tendons) can occur within 48 hours of starting quinolone treatment. | GUSTOIMAGES/SCIENCE PHOTO LIBRARY

The decision by the Medicines and Healthcare products Regulatory Agency (MHRA) to restrict the indications for quinolone antibiotics was based on recommendations from the the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee after it conducted a review of serious adverse effects reported with the use of quinolones given orally, parenterally or by inhalation.

Quinolone antibiotics are authorised for serious, life-threatening bacterial infections. Those currently available to prescribe in the UK include ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin.

The MHRA advises prescribers that systemic quinolones can very rarely cause long-lasting (up to months or years), disabling, and potentially irreversible adverse reactions, sometimes affecting multiple systems, organ classes and senses. 

Adverse effects may be delayed

Serious adverse effects reported include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell. Tendon damage occur within 48 hours of starting treatment with a quinolone but onset of signs and symptoms of adverse effects may be delayed several months after stopping treatment.

Advice to prescribers

In its latest Drug Safety Update the MHRA advises healthcare professionals that they should not prescribe quinolones for:

  • non-severe or self-limiting infections, or non-bacterial conditions
  • some mild to moderate infections (such as in acute exacerbation of chronic bronchitis and COPD) unless other antibiotics commonly recommended for these infections are considered inappropriate.*

In addition, ciprofloxacin or levofloxacin should no longer be prescribed for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate.*

Prescribers should advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain or weakness, joint pain or swelling, peripheral neuropathy, or central nervous system effects, and to contact their doctor immediately for further advice.

Avoid in at-risk patients

Use of quinolones should be avoided in patients who have previously experienced serious adverse reactions with a quinolone. Quinolones should also be prescribed with special caution in patients at increased risk of tendon injury, including those over 60 years of age and those with renal impairment or solid organ transplants.

Use of a corticosteroid with a quinolone should also be avoided as co-administration could exacerbate quinolone-induced tendinitis and tendon rupture.

The MHRA states that Summaries of Product Characteristics for affected drugs will be updated imminently.

*Relevant situations in which other antibiotics may be considered inappropriate include: those where there is resistance to first-line antibiotics recommended for these infections; when other first-line antibiotics are contraindicated or cause side effects that lead to cessation of treatment; or when first-line antibiotics have failed.

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