Abstract
Aims and Objectives: recent referral procedures by EMA reported association between use of fluoroquinolone antibiotics and increased risk of heart valve regurgitation/incompetence, aortic aneurysm or dissection. We present here a qualitative retrospective assessment of these risks in adults treated with different levofloxacin formulations by using first data collection for pharmacovigilance signal detection.
Methods: The EMA safety database (EudraVigilance) was searched for adverse drug reactions (ADRs) from March 2003 (first collected event) up to 31 March 2021 using electronic reaction monitoring report (eRMR) generated to identify new signals of disproportionate reporting (SDRs). Any occurred ADR was manually sorted out by MedDRA High Group Level Term (HGLT) for Aneurysms and artery dissections, Cardiac valve disorders, and some preferred terms (PTs) from CNS vascular disorders by their occurrence in oral, intravenous, inhaled and unknown levofloxacin formulations.
Results: out of 112470 electronically reported reactions, the figures of the MedDRA HGLT ones are shown (Table) by route of administration.
Levofloxacin ADRs by MedDRA HGLT (PTs) | Total | Inhaled | Oral | i.v. | Unknown |
Aneurysms and artery dissections (All PTs) | 53 | 0 | 24 | 3 | 26 |
Cardiac valve disorders (All PTs) | 32 | 0 | 17 | 4 | 11 |
CNS vascular disorders (selected PTs) - cerebral ischaemia, ischaemic cerebral infarction, transient ischaemic attack, subarachnoid haemorrhage | 46 | 1 | 19 | 3 | 23 |
Conclusions: Over the 17-years observation period, one ADRs analysed occurred with inhaled levofloxacin formulations. The role of the inhalation route in reducing the occurrence of ADR needs to be further validated.
Footnotes
Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA3308.
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2021