Communication on behalf of the EAU Urological Infections Guidelines Panel and the EAU Section of Infections in Urology
Date: 3rd June 2019
Re: European Commission ruling on the indications for use of fluoroquinolones
To whom it may concern,
On the 11th March 2019 the European commission (EC) implemented stringent regulatory conditions regarding the use of fluoroquinolones (e.g. Ciprofloxacin, Levofloxacin, Moxifloxacin, Norfloxacin, Ofloxacin) in urology. This legally binding decision is applicable in all EU countries and is based on a review of the serious disabling and potentially permanent side effects associated with the administration of quinolone and fluoroquinolone antibiotics by mouth, injection or inhalation.
Fluoroquinolones should not be used for the:
1. Prevention of recurrent urinary tract infections.
2. Prevention of infection after surgeries or interventions in the urogenital system, including transurethral surgery or transrectal prostate biopsy
3. Treatment of sepsis
Other indications have been maintained e.g. treatment of complicated UTI and bacterial prostatitis; restricted; or reworded according to the current medical knowledge.
Guidelines for the correct use of antibiotics must be followed and urologists are obligated to consider the serious side effects associated with fluoroquinolones and participate in shared medical decision making with patients who have an elevated risk of complication. More information on this topic can be accessed via the European Medicines Agency website: https://www.ema.europa.eu/en/medicines/human/referrals/quinolone-fluoroquinolone-containing-medicinal-products
On behalf of the EAU Urological Infections Guidelines Panel and the EAU Section of Infections in Urology.
Prof. Dr. F. Wagenlehner