Fluoroquinolone antibiotics - severe adverse effects

Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate 22/1/24

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

Fluoroquinolone antibiotics: suicidal thoughts and behaviour 26/9/23

MHRA Drug Safety Update September 2023

Fluoroquinolone antibiotics are associated with a risk of psychiatric reactions, including depression and psychotic reactions, which may potentially lead to thoughts of suicide or suicide attempts.

• advise patients to carefully read the advice in the Patient Information Leaflet about possible psychiatric reactions, and to seek medical advice if they experience these symptoms
• when prescribing a fluoroquinolone, advise patients to be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment
• note that fluoroquinolones can exacerbate existing psychiatric symptoms
• advise patients to seek medical advice if they develop such thoughts or behaviours, and ensure that a suitable referral for treatment is made, if necessary
• fluoroquinolones should be discontinued at the first signs of a serious adverse reaction, including new or worsening depression or psychosis

Advice for healthcare professionals to give to patients and caregivers:

• fluoroquinolone antibiotics are a group of antibiotics that include ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin – sometimes these medicines may also have a brand name so patients should check the details of all antibiotics prescribed to them
• if you are prescribed one of the antibiotics listed above and you suffer from depression or psychosis, tell your healthcare professional – this is important as your symptoms may become worse under treatment
• psychiatric reactions include confusion, disorientation, anxiety, depression and suicidal thoughts or suicide attempts
• you may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking these medicines, and that they have rare psychiatric side effects associated with them – others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about
• if you develop thoughts of suicide or have attempted suicide, do not take any further doses of your fluoroquinolone, and talk to your doctor or another healthcare professional immediately

Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk  17/12/20

MHRA Drug Safety Update December 2020

Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for heart valve regurgitation (incompetence).

Advice for healthcare professionals:

• Fluoroquinolones are authorised for use in serious, life-threatening bacterial infections
• Systemic (by mouth or injection) and inhaled fluoroquinolones have been associated with a small increased risk of heart valve regurgitation, with one retrospective case-control study suggesting a 2-fold increased relative risk with current oral fluroquinolone use compared with the risk with use of amoxicillin or azithromycin
• Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in the following patients at risk:
  • Patients with congenital heart valve disease or pre-existing heart valve disease
  • Patients diagnosed with connective tissue disorders (for example, Marfan syndrome or Ehlers-Danlos syndrome)
  • Patients with other risk factors or conditions predisposing for heart valve regurgitation (for example, hypertension, Turner’s syndrome, Behçet’s disease, rheumatoid arthritis, and infective endocarditis)
• Advise patients, especially those at risk, of the importance of seeking immediate medical attention if they experience:
  • A rapid onset of shortness of breath, especially when lying down flat in bed
  • Swelling of the ankles, feet, or abdomen
  • New-onset heart palpitations
• Due to the small increased risk of aortic aneurysm and dissection, MHRA have previously advised that fluoroquinolones should only be used after careful assessment of the benefits and risks in patients at risk of aneurysms and after consideration of other therapeutic options
• Fluoroquinolones have also been associated with disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems – treatment should be discontinued at the first signs of a serious adverse reaction, including tendon pain or inflammation 

Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; advice for prescribing in high-risk patients November 2018

MHRA Drug Safety Update November 2018

Advice for healthcare professionals:

• Systemic (by mouth or injection) and inhaled fluoroquinolones may be associated with a small increased risk of aortic aneurysm and dissection, particularly in older patients
• Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for aortic aneurysm and dissection
• Conditions predisposing to aortic aneurysm and dissection include:
  • A family history of aneurysm disease
  • Diagnosis with pre-existing aortic aneurysm and/or aortic dissection
  • Other risk factors or conditions predisposing for aortic aneurysm and dissection (for example, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, and known atherosclerosis)
• Advise patients, particularly elderly people and those at risk, about rare events of aortic aneurysm and dissection and of the importance of seeking immediate medical attention in case of sudden-onset severe abdominal, chest or back pain

Fluoroquinolone antibiotics: Reminder of the risk of disabling and potentially long-lasting or irreversible side effects 30/8/23

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 systems, organ classes, and senses
• despite new restrictions and precautions introduced in 2019, a new study has shown no evidence of a change in fluoroquinolone prescribing patterns in the UK, and the MHRA has continued to receive Yellow Card reports of these side effects
• advise patients to stop 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 for further advice – sheet for patients
• do not prescribe fluoroquinolones:
  • for non-severe or self-limiting infections, or non-bacterial conditions, for example non-bacterial (chronic) prostatitis
  • for mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease) unless other antibiotics that are commonly recommended for these infections are consider inappropriate (see below)
• do not prescribe ciprofloxacin or levofloxacin for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below)
• 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 use of a corticosteroid with a fluoroquinolone since coadministration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture

Advice for healthcare professionals to give to patients and caregivers:

• fluoroquinolone antibiotics are a group of antibiotics that include ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin – sometimes 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 your shoulders, arms, or legs
  • abnormal pain or sensations (such as persistent pins and needles, tingling, tickling, numbness, or burning), weakness in your body, especially in the legs or arms, or difficulty walking
  • severe tiredness, depressed mood, anxiety, or 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 during or shortly after taking a fluoroquinolone – this means you should avoid them in the future