TY - JOUR
PY - 2022//
TI - Association between road traffic accidents and drugs belonging to the anti-seizure medications class: a pharmacovigilance analysis in VigiBase®
JO - British journal of clinical pharmacology
A1 - Chrétien, Basile
A1 - Nguyen, Sophie
A1 - Dolladille, Charles
A1 - Morice, Pierre-Marie
A1 - Heraudeau, Marie
A1 - Loilier, Magalie
A1 - Fedrizzi, Sophie
A1 - Bourgine, Joanna
A1 - Cesbron, Alexandre
A1 - Alexandre, Joachim
A1 - Bocca, Marie-Laure
A1 - Freret, Thomas
A1 - Lelong-Boulouard, Véronique
SP - ePub
EP - ePub
VL - ePub
IS - ePub
N2 - AIM: Due to their central mechanism of action, anti-seizure medications (ASMs) could lead to adverse effects likely to impair driving skills. Their extended use to neuropsychiatric disorders makes it a class of drugs to monitor for their road traffic accidental (RTA) potential. We aimed to assess the reporting association between ASMs and RTA using the WHO pharmacovigilance database (Vigibas®).
METHODS: We performed a disproportionality analysis to compute adjusted reporting odds ratios (aROR) to evaluate the strength of reporting association between ASMs and RTAs. A univariate analysis using the reporting odds-ratio was used to assess drug-drug interactions (DDI) between ASMs and RTAs.
RESULTS: There were 1,341,509 reports associated with at least one ASM in Vigibase® of whom 2.91‰ were RTAs reports. Eight ASMs were associated with higher reporting of RTAs compared to others (ranging from 1.35 (95% CI 1.11-1.64) for lamotrigine to 4.36 (95% CI 3.56-5.32) for cannabis). Eight significant DDI were found between ASMs and the onset of RTA, mainly involving CYP450 induction.
CONCLUSION: A significant safety signal between RTAs and some ASMs was identified. Association of several ASMs might further increase the occurrence of RTA. ASMs prescription in patients with identified risk factors of RTA should be considered with caution. Study number: ClinicalTrials.gov, NCT04480996.
Language: en
LA - en SN - 0306-5251 UR - http://dx.doi.org/10.1111/bcp.15481 ID - ref1 ER -