GPs should only prescribe fluoroquinolone antibiotics when ‘no other antibiotics are appropriate for use’, according to new MHRA guidance.
From today, 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 which said that fluoroquinolones should not be prescribed for ‘mild to moderate or self-limiting infections, or non-bacterial conditions’.
The guidance followed a review into the risk of potentially long-term adverse reactions to fluoroquinolone antibiotics.
The MHRA considered evidence including Yellow Card reports submitted by patients and healthcare professionals and the experiences of people affected by side effects.
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.
‘Please continue to report any suspected adverse reactions to fluoroquinolones via the Yellow Card scheme.’
MHRA 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 body systems and senses
- the UK indications for systemic fluoroquinolones have been updated so they must only be used in situations when other antibiotics, that are commonly recommended for the infection, are inappropriate
- situations in which other antibiotics are considered to be inappropriate and where a fluoroquinolone may be indicated are where:
- there is resistance to other first-line antibiotics recommended for the infection
- other first-line antibiotics are contraindicated in an individual patient
- other first-line antibiotics have caused side effects in the patient requiring treatment to be stopped
- treatment with other first-line antibiotics has failed
- this goes further than previous measures which set out that fluoroquinolones should not be prescribed for non-severe or self-limiting infections, or non-bacterial conditions, for example non-bacterial (chronic) prostatitis. These measures are still in place
- as a reminder, patients should be advised to stop fluoroquinolone 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
- refer to MHRA’s sheet for patients ( or ) for further advice
- remain alert to the risk of suicidal thoughts and behaviours with use of fluoroquinolone antibiotics. A reminder about these risks was published in the September 2023 issue of Drug Safety Update
- as a reminder of advice published in our August 2023 issue of Drug Safety Update:
- 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 coadministration of a corticosteroid with a fluoroquinolone since this 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
Source: MHRA
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.
Meanwhile, NHS England said it will monitor the Pharmacy First service after its launch for any potential impact on antimicrobial resistance.
When the scheme was announced GPs told Pulse that there are concerns around antibiotic stewardship.
READERS' COMMENTS [2]
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Still first line for otitis externa which is a topical treatment and at such a high local dose that resistance is not a problem. Safe because not systemic and not ototoxic.
What about agriculture eh!