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Only prescribe fluoroquinolone antibiotics as last resort, says MHRA drug safety update

Fluoroquinolone antibiotics should only be prescribed when ‘no other antibiotics are appropriate for use’, according to a new MHRA drug safety update.

From 22 January 2024, fluoroquinolone antibiotics given systemically – by mouth, injection or inhalation – must only be administered when other recommended antibiotics ‘have failed, will not work due to resistance, or are unsafe to use in an individual patient’, the regulatory agency said.

This is a strengthening of previous regulations from August 2023, which said that fluoroquinolones should not be prescribed for mild-to-moderate or self-limiting infections, or non-bacterial conditions.

The updated drug safety update followed a review into the risk of long-lasting or disabling reactions to fluoroquinolone antibiotics.

The MHRA considered advice from the Commission on Human Medicines and evidence such as Yellow Card reports submitted by patients and healthcare professionals, as well as the experiences of people affected by side effects.

Reports of serious adverse reactions to fluoroquinolone antibiotics have included tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects.

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MHRA chief safety officer Dr Alison Cave said: ‘Patient safety is our top priority. 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. That’s why, from today, fluoroquinolones should only be prescribed when usage of other antibiotics is inappropriate. Fluoroquinolones use should be discontinued at the first signs of a serious adverse reaction.

‘Patients using fluoroquinolone antibiotics should carefully read the advice in the patient information leaflet about possible adverse reactions and seek immediate medical advice if they experience any side effects involving symptoms relating to tendons, muscles, joints, nerves or mental health at any point during treatment.’

The MHRA has reminded healthcare professionals to remain alert to the risk of suicidal thoughts and behaviours with use of fluoroquinolone antibiotics, and to continue to report any suspected adverse reactions to fluoroquinolones via the Yellow Card scheme.

In 2018, the European Medicines Agency called for certain medicines containing this class of antibiotics to be suspended, and for others to be restricted.

Restrictions to the use of fluoroquinolones were introduced in 2019 to minimise the risk of long-lasting or disabling reactions.