Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilance Database (VigiBase^®).

ABSTRACT:

Introduction

Published data on the safety of biologics other than tumor necrosis factor (TNF) inhibitors during pregnancy are limited.

Objective

The aim was to detect pharmacovigilance signals for fetal and neonatal adverse drug reactions (ADRs) to biologics taken by pregnant women with autoimmune diseases.

Methods

We performed a disproportionality analysis of the World Health Organization's VigiBase^® pharmacovigilance database from 1968 to June 1, 2021. Data were collected in June 2021. By using terms for different hierarchical levels of the Medical Dictionary for Regulatory Activities, we selected the following fetal or neonatal ADRs: stillbirth, premature birth, low birth weight, small for gestational age, and congenital malformations. The frequency of a

SUBMITTER: Dernoncourt A 

PROVIDER: S-EPMC9676840 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature