Fluoroquinolone antibiotics - Position on use in paediatric patients
Position on the use of fluoroquinolones in paediatric patients
The MHRA released a Drug Safety Update in January 2024, restricting the use of fluoroquinolones:
Paediatric ID response to the Drug Safety Update which highlights potential risks of using fluoroquinolones:
- The guidance has been reviewed for its application to paediatric patients and each paediatric antimicrobial guideline containing fluoroquinolones has been reviewed to evaluate the risk-benefit of using fluoroquinolones, with the aim to replace with suitable alternatives whenever possible.
Risks highlighted in the Drug Safety Updates on fluoroquinolones:
- Alert on the risk of Suicidal thoughts and behaviours with use of fluoroquinolone antibiotics (2023): Consider this risk in adolescent patients on prolonged courses of fluoroquinolones (i.e. for spinal infections).
- Alert on the Small increased risk of aortic aneurysm and dissection; advice for prescribing in high-risk patients (2018): Unlikely to affect paediatric patients as the evidence is mainly in adult patients.
- Alert on the Small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk (2020): Unlikely to affect paediatric patients as the evidence is mainly in adult patients.
- Reminder of the risk of disabling and potentially long-lasting or irreversible side effects (2023): The risk of irreversible cartilage damage mainly affects adult patients.
Fluoroquinolone antibiotics - advice for prescribers
Fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) have been associated with a number of severe adverse effects, mainly affecting adult patients. The use of fluoroquinolones is restricted. General principles for these antibacterials are:
- DO NOT prescribe for:
- non-severe or self-limiting infections.
- mild to moderate infections (unless other antibiotics that are commonly recommended for these infections are considered inappropriate).
- DO prescribe as per Trust Antimicrobial Guidelines or paediatric Micro/ID advice.
- DO ensure penicillin allergies are properly clarified and consider delabelling in appropriate patients to avoid the use of fluoroquinolones.
- DO ensure all patients are given the MHRA fluoroquinolone patient leaflet (this is usually given to patients with their discharge and outpatient medications).
Report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app
Advice for patients and caregivers
- Fluoroquinolones are a class of antibiotics that include ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin – 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. These effects have been mainly seen in adult patients
- 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 joints such as in the shoulders, arms, or legs
- Abnormal pain or sensations (such as persistent pins and needles, tingling, tickling, numbness, or burning), weakness in the legs or arms, or difficulty walking
- Severe tiredness, depressed mood, anxiety, 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 at any point while taking a fluoroquinolone – this means you should avoid them in the future