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Fluoroquinolones must only be prescribed when other antibiotics have failed, will not work because of antibiotic resistance, or are unsafe to use for an individual patient, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.
In a drug safety update, published on 22 January 2024, the MHRA said the new restrictions for fluoroquinolones given by mouth, injection or inhalation follows a review of measures to reduce the risk of potentially long-term or irreversible side effects, such as tendonitis and tendon rupture.
The MHRA previously restricted use of fluoroquinolones in March 2019, stating that they should not be prescribed for mild-to-moderate or self-limiting infections, or non-bacterial conditions, such as non-bacterial (chronic) prostatitis.
In August 2023, the MHRA published a reminder of the risks of fluoroquinolone use, following results of a study led by the European Medicines Agency, which showed no evidence of a change in fluoroquinolone prescribing patterns in the UK despite the 2019 restrictions.
The retrospective population-based cohort study, published in March 2023, reported that although there was around a 25% reduction in primary care fluoroquinolone prescriptions in the UK between 2016 and 2021, this was not associated with regulatory interventions implemented in 2018/2019.
In the updated restrictions, the MHRA also advises avoiding fluoroquinolone use in patients who have previously had serious adverse reactions to the drugs and to avoid co-administration with a corticosteroid.
The restrictions say special caution should be taken for people older than 60 years, with renal impairment or solid-organ transplant, owing to increased risk of tendon injury.
“Restrictions have been introduced following Yellow Card reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, in some cases prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions,” the MHRA said in a statement.
Elisha Zafar, specialist infection pharmacist at King’s College Hospital NHS Foundation Trust, said the new restrictions “will definitely impact both primary and secondary care and hopefully will imply tighter restrictions with usage of fluoroquinolones”.
“Work really needs to be done now to change habitual decision making when prescribing these antibiotics, especially given [their] ease of use for certain indications when a penicillin is first line but an allergy is present,” she said.
“Further to this, another major impact that will reduce fluoroquinolone use would be to increase the penicillin allergy delabelling, which is an important drive within antimicrobial stewardship at the moment. This will hopefully enable practitioners to increase penicillin usage instead of more harmful alternatives like fluoroquinolones.”
Zafar added that, following the MHRA’s announcement, prescribers should receive safety information “across each trust to highlight these measures and the potential risks associated with [fluoroquinolone] prescribing”.
Alison Cave, chief safety officer at the MHRA, said: “We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.
“We recognise fully the importance of limiting the use of these medicines. Fluoroquinolones should only be prescribed when usage of other antibiotics is inappropriate, and discontinued at the first signs of a serious adverse reaction,” she added.
