Safety updates

Due to the risk of healthcare associated infection (including those due to MRSA and Clostridium difficile) quinolone use should be avoided unless there is a clear indication for their use. They should only be prescribed in accordance with guidelines. The shortest effective duration should be prescribed.

MHRA Drug Safety Update (November 2018 & December 2020): Systemic and inhaled fluoroquinolones: small risk of aortic aneurysm and dissection & small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk

• Systemic (by mouth or injection) and inhaled fluoroquinolones have been associated with a small increased risk of aortic aneurysm and dissection, particularly in older patients, and of heart valve regurgitation. Refer to the drug safety updates for information on the increase in risk of these events.
• Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk of aortic aneurysm or heart valve regurgitation.
• 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, Behçet’s disease, hypertension, and known atherosclerosis).
• Patients at risk of heart valve regurgitation include:
  • 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, particularly elderly people and those at risk, of the importance of seeking immediate medical attention if they experience:
  • sudden-onset severe abdominal, chest or back pain
  • 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.

MHRA Drug Safety Update (September 2023): Fluoroquinolone antibiotics: suicidal thoughts and behaviour

• 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.

MHRA Drug Safety Update (January 2024): Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate

• 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.
• As a reminder of advice published in the 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.

Many antibiotics penetrate the prostate poorly, but fluoroquinolones reach therapeutic levels in the prostate and therefore remain an appropriate first line option in acute prostatitis.

Ciprofloxacin

• Tablets 250mg, 500mg (£0.80, £1.02 = 10 tablets)
• Oral suspension 250mg/5ml (£21.29 = 100ml)
• Intravenous infusion 200mg/100ml, 400mg/200ml

Indications

• Pyelonephritis (acute)
  • Non-pregnant women and men aged 16 years and over
• Catheter-associated UTI if upper symptoms
  • Non-pregnant women and men aged 16 years and over
• Prostatitis (acute) - (first line)
• Gonorrhoea - (specialist input)

Notes

1. Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate (see MHRA Drug Safety Update above)
2. Patients should be advised 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, feet, or abdomen swelling, peripheral neuropathy, rapid onset of shortness of breath, new-onset of heart palpitations, and central nervous system effects: including new or worsening depression or psychosis, and to seek immediate medical attention.
3. Ciprofloxacin increases plasma theophylline levels.
4. Ciprofloxacin has only a limited license for use in children.
5. At appropriate doses oral ciprofloxacin is extremely well absorbed and blood levels are obtained which are comparable to those obtained by intravenous administration. Patients should be transferred to oral therapy at the earliest opportunity.

Levofloxacin

• Tablets 250mg, 500mg (£8.23, £19.74 = 10 tablets)
• Intravenous infusion 500mg/100ml
• Nebuliser solution ampoules 240mg 

Indications

• Eradication of H. pylori (unlicensed)
• Pyelonephritis (acute)
  • Non-pregnant women and men aged 16 years over
• Catheter-associated UTI if upper symptoms
  • Non-pregnant women and men aged 16 years and over
• Chronic Pseudomonas lung infection in cystic fibrosis in adults (hospital only) (see note 3)
  

Notes

1. Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate (see MHRA Drug Safety Update above)
   
2. Patients should be advised 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, feet, or abdomen swelling, peripheral neuropathy, rapid onset of shortness of breath, new-onset of heart palpitations, and central nervous system effects: including new or worsening depression or psychosis, and to seek immediate medical attention.
3. NHS England (NSHE) will routinely commission levofloxacin nebuliser solution for chronic Pseudomonas lung infection in cystic fibrosis (adults) (see NHSE Commissioning Policy for more details).

Ofloxacin

• Tablets 200mg (£11.68 = 10 tablets), 400mg (£12.76 = 5 tablets)

Indications

• Chlamydia trachomatis
• Prostatitis (acute) - (first line)

Notes

1. Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate (see MHRA Drug Safety Update above)
2. Patients should be advised 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, feet, or abdomen swelling, peripheral neuropathy, rapid onset of shortness of breath, new-onset of heart palpitations, and central nervous system effects: including new or worsening depression or psychosis, and to seek immediate medical attention.

Moxifloxacin

• Tablets 400mg
• Infusion 400mg/250ml

Notes

1. Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate (see MHRA Drug Safety Update above)
2. Patients should be advised 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, feet, or abdomen swelling, peripheral neuropathy, rapid onset of shortness of breath, new-onset of heart palpitations, and central nervous system effects: including new or worsening depression or psychosis, and to seek immediate medical attention.