Fluoroquinolone use and aortic aneurysm or dissection: a German cohort study based on nationwide SHI-physicians outpatient claims data confirms increased risk.

BACKGROUND: Acute aortic dissection (AAD) is a potentially life-threatening condition with an annual incidence of approximately 6.0–16.9 per 100,000 inhabitants. Fluoroquinolone use has been identified as a potential risk factor for aortic aneurysm/acute aortic dissection (AA/AAD), leading to restrictions on their clinical indication. As adverse drug reactions (ADRs) are a key issue in pharmacovigilance, this study addresses two questions: First, can the reported association between fluoroquinolones and AA/AAD be confirmed in German routine healthcare data? Second, is there an association with the risk of AA/AAD, considering the role of underlying infections? METHODS: We analyzed prescription and diagnostic data of statutory health insurance patients in Germany (~ 87% of the population) between 2009 and 2017. Patients treated with fluoroquinolones were compared with a propensity score-matched control group treated with other non-fluoroquinolone antibiotics. Cox proportional hazards models were used to estimate hazard ratios (HRs) for aortic aneurysm and dissection. Graph-theoretic methods were applied to identify morbidity-related variables for propensity score matching. RESULTS: Patients treated with fluoroquinolones had a higher risk of developing AA/AAD compared to those treated with other antibiotics (HR: 1.56). In sensitivity analyses excluding patients with pneumonia or aortic dissection, the risk was slightly reduced (HR: 1.43). The HR remained elevated even when adjusted for underlying infections, sex and age (HR: 1.48), indicating a potential drug-related effect independent of specific infections. CONCLUSIONS: Fluoroquinolone use is associated with an increased risk of aortic aneurysm and dissection. These findings highlight the value of routine healthcare data in detecting adverse drug reactions and underline the need for careful risk–benefit evaluation when prescribing fluoroquinolones.