Optimizing responses to drug safety signals in pregnancy: the example of dolutegravir and neural tube defects.

ABSTRACT:

Introduction

The unexpected identification of a neural tube defect (NTD) safety signal with preconception dolutegravir (DTG) exposure in the Botswana Tsepamo birth outcomes study brought into sharp focus the need for reliable data on use of new antiretrovirals in pregnancy, improved pharmacovigilance systems to evaluate safety of new drugs being introduced into populations including women of reproductive potential, and balanced risk-benefit messaging when a safety signal is identified.

Discussion

The Tsepamo study NTD safety signal and accompanying regulatory responses led to uncertainty about the most appropriate approach to DTG use among women of reproductive potential, affecting global DTG roll-out plans, and limiting DTG use in adolescent girls and women. It also reveale

SUBMITTER: Mofenson LM 

PROVIDER: S-EPMC6625340 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature