Journal Articles | February 2020

Optimizing responses to drug safety signals in pregnancy

The example of dolutegravir and neural tube defects

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Overview

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.

Country:

Global

Topics:

Dolutegravir & Pregnancy; Maternal & Child Health; Prevention of Mother-to-Child Transmission

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Founded over 30 years ago, The Elizabeth Glaser Pediatric AIDS Foundation is committed to a comprehensive response to fighting HIV and AIDS through research, global advocacy, strengthening of local health care systems, and growing the capacity of governments and communities in the world’s most affected regions to respond to urgent needs. We’re driven to see a world where no other mother, child, or family is devastated by this disease.

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