MHRA says fluoroquinolones should be administered only when no other antibiotics are appropriate

February 9th, 2024
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The Medicines and Healthcare products Regulatory Agency has issued new restrictions on fluoroquinolone use, following reports of serious adverse reactions in patients.

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 follow 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 the 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.

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