NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update

Fluoroquinolone safety – new restrictions

Reports of adverse events associated with fluoroquinolone use prompted a recent EU safety review. As a result, new restrictions and precautions have been implemented regarding the use of fluoroquinolones.  Those commonly prescribed include ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin and ofloxacin.

Systemic fluoroquinolone use can very rarely cause prolonged (up to months or years), disabling and potentially permanent adverse events.  These effects may affect multiple systems, organ classes and senses. Serious adverse effects include tendon damage and neuropathy, aortic aneurysm, QT prolongation, C.difficile and seizures.

Key messages

 Fluoroquinolones should:

  • only be used for treatment of severe bacterial infections when first line recommended antibiotics cannot be used.  Refer to NHSGGC Infection guidelines on StaffNet or the infection section of the GGC Adult Therapeutics Handbook for appropriate indications.
  • not be used for prophylaxis of recurrent lower urinary tract infections or traveller’s diarrhoea. 
  • be avoided in patients with a previous history of fluoroquinolone or quinolone related serious adverse drug reaction or C.difficile.
  • be used with caution, particularly among patients aged > 60 years and those with renal impairment or solid-organ transplants, due to the higher risk of tendon injury.
  • be used with extreme caution in combination with corticosteroids as this could exacerbate fluoroquinolone-induced tendinitis and tendon rupture.
  • be stopped immediately at the first signs of a serious adverse reaction.
  • A patient information leaflet (PIL) should be provided with each supply of a fluoroquinolone (this can be the original manufacturers PIL, if available, or the MHRA document).
  • This advice applies to all oral, parenteral and inhaled preparations. Refer to the MHRA alerts issued in November 2018 and March 2019 for further information.

Click here for further information on the following safety issues to be considered before prescribing fluoroquinolones:

Tendon Damage and Neuropathy

Aortic Aneurysm

QTc Prolongation

Seizures 

C. difficile

Drug Interactions

 

Remember to report all suspected adverse drug reactions to the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or via the App (visit the App store or Google play).

 

Published 15/05/19. Medicines Update blogs are correct at the time of publication.