Fluoroquinolones only if other antibiotics are inappropriate

Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate. This follows a review by the MHRA which looked at the effectiveness of current measures to reduce the identified risk of disabling and potentially long-lasting or irreversible side effects.

MHRA Alert, 22 January 2024

Note that the information in this MHRA alert if taken from the MHRA Drug Safety Update on Gov.UK. You may find the full alert, including additional background information, here.

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 (regular print or large print) 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 (download it from the Apple App Store, or Google Play Store)

Advice for healthcare professionals to give to 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
• 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

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