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Fluoroquinolone-Induced Photosensitivity: A Chemical Fragment-Based Approach by a Case/Non-case Study in VigiBase®
Yoann Zelmat1, Vanessa Rousseau2,3, Leila Chebane2
1Service de Pharmacologie Médicale et Clinique, Centre Régional de Pharmacovigilance, Centre Hospitalier Universitaire de Toulouse, Toulouse, France. yoann.zelmat@gmail.com.
Introduction:
Fluoroquinolones are widely used to treat bacterial infections. Many in vitro and in vivo studies have established a chemical relationship between fluoroquinolones' particular chemical structure and photosensitivity. The aim of this study was to establish a relationship between the chemical structure of fluoroquinolones and the risk of photosensitivity adverse effects from real-world data.
Methods:
All the Individual Case Safety Reports (ICSRs) related to fluoroquinolones and registered in the World Health Organization global database (VigiBase®) up to December 31, 2017 were collected. A disproportionality analysis was performed in order to quantify the photosensitivity risk for each fluoroquinolone by calculating their reporting odds ratio (ROR).
Results:
Up to December 31, 2017, 282,805 ICSRs related to fluoroquinolones were selected, of which 1647 were photosensitivity adverse event cases. Sparfloxacin had the highest adjusted ROR of 161.10 (95% confidence interval [CI] 133.66-194.02) followed by grepafloxacin (40.30 [26.30-59.60]) closely followed by lomefloxacin (32.61 [28.61-37.07]), then enoxacin (11.04 [8.33-14.32]) and fleroxacin (8.22 [5.06-12.56]).
Conclusion:
This study confirms the high reporting rate of photosensitivity adverse effects for sparfloxacin from real-world data. Moreover, our data suggest more photosensitivity adverse effects reporting for fluoroquinolones with a halogen at their 8th position.
