No specific maternal toxicities, patterns of major birth defects, or increased reporting of spontaneous abortion were found in safety reports retrieved from the WHO Pharmacovigilance database up to the end of 2019. However, continuous surveillance is required in pregnant and lactating women exposed to these drugs owing to the relatively limited number of adverse drug reactions reported and the lack of long-term safety data.
Of 94 safety reports in the VigiBase, drug exposure occurred in 85 cases (90.4%) during pregnancy, five (5.3%) before pregnancy and one (1.1%) during lactation. Fifty one reports (54.3%) consisted only of drug exposure, while 43 (45.7%) additionally reported a total of 47 adverse drug reactions including 18 maternal toxicities (18), one poor breastfeeding, 23 spontaneous abortions, three preterm birth/prematurity, and two birth defects.
There was no signal of disproportionate reporting for spontaneous abortion compared to the full database (reporting odds ratio 1.46, 95% confidence interval 0.97-2.20). However, when triptans were used as comparator, a signal of disproportionate reporting for spontaneous abortion was detected in association with erenumab, galcanezumab, and fremanezumab (reporting odds ratio 1.86, 95% confidence interval 1.12-3.13). This was not statistically significant after excluding confounded safety reports (reporting odds ratio 1.21, 95% confidence interval 0.67-2.21).
Noseda R, Bedussi F, Gobbi C et al. Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: Analysis of the WHO pharmacovigilance database. Cephalalgia 2021 Jan 12; Online ahead of print.