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Direct Healthcare Professional Communication (DHPC) on systemic and inhaled fluoroquinolone antibiotics: reminder on restrictions of use

Active substance: ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin

Ciprofloxacin, Delafloxacin, Levofloxacin, Moxifloxacin, Norfloxacin, Ofloxacin

The marketing authorisation holders of fluoroquinolone antibiotics in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to remind of the recent study data which suggest that fluoroquinolones continue to be prescribed outside of the recommended uses. Systemic and inhaled fluoroquinolones are associated with very rare, serious, disabling, long-lasting and potentially irreversible adverse reactions. These products should be prescribed only for approved indications and after careful assessment of the benefits and risks in the individual patient.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 379KB, File does not meet accessibility standards