5PSQ-031 A two-year retrospective analysis of adverse drug reactions with fluoroquinolone and quinolone antibiotics

Background On 9 February 2017, the Pharmacovigilance Risk Assessment Committee (PRAC) initiated a review 1 of disabling and potentially long-lasting side effects reported with systemic and inhaled quinolone and fluoroquinolone antibiotics at the request of the German medicines authority, following reports of long-lasting side effects in the national safety database and the published literature. Purpose To review the adverse drugs reactions (ADRs) of systemic and inhaled fluoroquinolone and quinolone antibiotics that involved peripheral and central nervous system, tendons, muscles and joints reported from our Pharmacovigilance Department (PVD). Material and methods Retrospective analysis of ADRs reported in our PVD involving ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, rufloxacin, cinoxacin, nalidixic acid and pipemidic given systemically (by mouth or injection). The period considered was September 2016 to September 2018. Results Twenty-two ADRs were reported in our PVD involving fluoroquinolone and quinolone antibiotics in the period considered and that affected peripheral or central nervous system, tendons, muscles and joints. The mean patient age was 67.3 years (range: 17–92 years). 63.7% of the ADRs reported were serious, of which 22.7% caused hospitalisation and 4.5% caused persistent/severe disability. 81.8% of the ADRs were reported by a healthcare professional (physician, pharmacist or other) and 18.2% by patients or a non-healthcare professional. Fluoroquinolone and quinolone antibiotics reported in these ADRs were mainly used for urinary tract infections (40.9%) and respiratory tract infections (31.8%). Conclusion On 5 October 2018, the European Medicines Agency PRAC recommended restricting the use of fluoroquinolone and quinolone antibiotics 2 (used by mouth, injection or inhalation), that will become applicable only after the decision of the Committee for Medicinal Products for Human Use. In the meantime, this work could help in make the healthcare professionals aware of a range of possible side effects (apart from achilles tendon disorders) attributable to fluoroquinolone and quinolone antibiotics, and that could be life-changing and wide ranging. References and/or acknowledgements 1. EMA Quinolone and fluoroquinolone Article 31 referral – Notification. Available at https://www.ema.europa.eu/documents/referral/quinolone-fluoroquinolone-article-31-referral-notification_en.pdf (accessed 15 October 2018.) 2. EMA Quinolone and fluoroquinolone Article 31 referral – Recommendation provided by PRAC. Available at https://www.ema.europa.eu/documents/referral/quinolone-fluoroquinolone-article-31-referral-recommendation-provided-prac_en.pdf (accessed 15 October 2018.) No conflict of interest.