Fluoroquinolone antibiotics: reminder of the risk of disabling and potentially long-lasting or irreversible side effects (MHRA, 30 August 2023)

Summary

Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of disabling and potentially long-lasting or irreversible side effects. Do not prescribe fluoroquinolones for non-severe or self-limiting infections, or for 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. Fluoroquinolone treatment should be discontinued at the first signs of a serious adverse reaction, including tendon pain or inflammation.

Content

Advice for healthcare professionals:

• 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 systems, organ classes, and senses
• Despite new restrictions and precautions introduced in 2019, a new study has shown no evidence of a change in fluoroquinolone prescribing patterns in the UK, and the MHRA has continued to receive Yellow Card reports of these side effects.
• 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.
• Do not prescribe fluoroquinolones:
• for non-severe or self-limiting infections, or non-bacterial conditions, for example non-bacterial (chronic) prostatitis.
• for 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 consider inappropriate (see below)
• Do not prescribe ciprofloxacin or levofloxacin for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below).
• 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 use of a corticosteroid with a fluoroquinolone since coadministration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture
• Report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app (download it from the Apple App Store, or Google Play Store

Advice for healthcare professionals to give to patients and caregivers:

• Fluoroquinolone antibiotics are a group of antibiotics that include ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin – sometimes these medicines may also have a brand name so patients should check the details of all antibiotics prescribed to them.
• Fluoroquinolone antibiotics have been reported to cause serious side effects involving tendons, muscles, joints, nerves, or mental health – in some patients, these side effects have caused long-lasting or permanent disability.
• Stop taking your fluoroquinolone antibiotic and contact your doctor immediately if you have any of the following signs of a side effect:
• tendon pain or swelling – if this happens, rest the painful area until you can see your doctor
• pain in your joints or swelling in your shoulders, arms, or legs
• abnormal pain or sensations (such as persistent pins and needles, tingling, tickling, numbness, or burning), weakness in your body, especially in the legs or arms, or difficulty walking
• severe tiredness, depressed mood, anxiety, or problems with your memory or severe problems sleeping
• changes in your vision, taste, smell, or hearing
• tell your doctor if you have had any of the above effects during or shortly after taking a fluoroquinolone – this means you should avoid them in the future.