Fluoroquinolone safety – prescribing restrictions
Reports of adverse events associated with fluoroquinolone use prompted an EU safety review. As a result, restrictions and precautions were implemented regarding the use of fluoroquinolones. Those commonly prescribed include ciprofloxacin, levofloxacin, moxifloxacin 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 Adult Infection Management (nhsggc.org.uk) 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 and additional alert on small risk of heart valve regurgitation issued in December 2020.
-
Due to high oral bioavailability, prescribe oral ciprofloxacin (70-80% bioavailability) and oral levofloxacin (99-100% bioavailability) where possible. The usual adult ciprofloxacin oral dose (500mg 12 hourly) is higher than the IV ciprofloxacin dose (400mg 12 hourly) thus oral ciprofloxacin results in similar concentrations to IV ciprofloxacin.
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 (for information on cation interactions refer to GGC Medicines: Tetracycline and fluoroquinolone antibiotic 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).
Written by NHSGGC Antimicrobial Pharmacy Team in collaboration with the Communications subcommittee of ADTC.
Originally published 15/05/2019 and updated 05/05/2023. Medicines Update blogs are correct at the time of publishing.
If you would like to subscribe to Medicines Update or provide feedback on the blogs, email medicines.update@ggc.scot.nhs.uk.
Follow Medicines Update on Twitter @NHSGGCMeds