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What postmarketing data is available for patients who are pregnant or nursing and taking galcanezumab?
Eli Lilly and Company continues to monitor the postmarketing safety of galcanezumab. Reporting rates of pregnancy events from the Eli Lilly and Company spontaneous AE database are provided in this response.
Postmarketing Spontaneous Reports
Through September 27, 2020, the MedDRA term of maternal exposure during pregnancy has been rarely reported in the Eli Lilly and Company spontaneous AE database. Rarely reported is defined as an AE that has been reported at an estimated rate between ≥0.01% and <0.1% according to the reporting system information.1
Exposure during pregnancy, fetal exposure during pregnancy, maternal exposure before pregnancy, maternal exposure during breastfeeding, or maternal exposure timing unspecified, as well as paternal exposure during pregnancy have been very rarely reported. Very rarely reported is defined as an AE that has been reported at an estimated rate of <0.01%.1
Postmarketing data do not necessarily represent the rate of occurrence of an AE in a treated population, but they represent a reporting rate of a particular AE to the company. Spontaneous reporting of AEs can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an event.2
Spontaneous reporting has limited use due to
lack of control population
under-reporting or reporting bias, and
missing or incomplete information regarding medical history or concomitant medications.2
Postmarketing Spontaneous Reports From the WHO Pharmacovigilance Database
The WHO published a report of postmarketing pregnancy events reported by patients receiving either erenumab, galcanezumab, or fremanezumab through December 31, 2019.3 Reports classified in the "Pregnancy and neonatal topics" SMQ (MedDRA version 22.1) were retrieved from the WHO pharmacovigilance database of safety reports of suspected adverse drug reactions (VigiBase). This analysis included 94 safety reports from the specified SMQ, of which 31 were associated with galcanezumab, and of those 28 were safety reports reporting only drug exposure. The remaining 3 reports comprised 1 report of spontaneous abortion, and 2 reports of a maternal adverse drug reaction. Based on the VigiBase data, the WHO review of the use of CGRP mAbs in pregnancy and lactation did not identify
3Noseda 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. Published online January 12, 2021. http://dx.doi.org/10.1177/0333102420983292
AE = adverse event
CGRP = calcitonin gene-related peptide
mAb = monoclonal antibody
MedDRA = Medical Dictionary for Regulatory Activities
SMQ = standard MedDRA query
WHO = World Health Organization
Fecha de la última revisión:2021 M01 11
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