Sex differences in suspected adverse drug reactions of anti-seizure medications reported in EudraVigilance.

INTRODUCTION

Epilepsy is one of the most common neurological disorders and requires long-term treatment with anti-seizure medication (ASM) which may cause adverse drug reactions (ADRs). Our aims were to investigate potential sex differences in reporting suspected ADR (sADRs) of ASMs through studying their seriousness, outcomes and Sudden Unexpected Death in Epilepsy (SUDEP).

METHODS

Using EudraVigilance database, reported sADRs with different ASMs over a ten year period were extracted. List of ASMs was compiled according to Anatomical Therapeutic Chemical Classification System. Reporting Odds Ratio (ROR), 95 % confidence interval (95 % CI), p-value were calculated.

RESULTS

In general, more sADRs were reported from females (603,936, 57.46 %). Males showed positive association with the following seriousness criteria: 'life threatening' (ROR=1.02, 95 %CI: 1.01-1.04; p < 0.001), 'caused/prolonged hospitalisation' (ROR=1.06, 95 %CI: 1.05-1.07; p < 0.001), 'results in death' (ROR=1.44, 95 %CI: 1.43-1.46; p < 0.001), and 'congenital anomaly' (ROR=2.43, 95 %CI: 2.41-2.45; p < 0.001). Only with 'not recovered / not resolved' outcome criteria showed negative association in males (ROR=0.72, 95 %CI: 0.70-0.73; p < 0.001), the other outcome criteria demonstrated positive association in the followings: 'fatal' (ROR=1.43, 95 %CI: 1.41-1.45; p < 0.001), 'recovered / resolved' (ROR=1.08, 95 %CI: 1.07-1.09; p < 0.001), 'recovered / resolved with sequelae' (ROR=1.06, 95 %CI: 1.01-1.12; p < 0.001), and 'recovering / resolving' (ROR=1.14, 95 %CI: 1.12-1.15; p < 0.001).

CONCLUSION

Differences were observed between males and females, particularly in terms of seriousness criteria, worse outcomes but prone to recover, and associations with SUDEP to the detriment of males. When choosing an ASM for a patient or especially if the patient has previously experienced an adverse drug reaction. these aspects can also be taken into account and may be important.