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Article

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

1 Jul 2019

Abstract excerpt

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...

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PMID: 31298496
DOI: 10.1002/jia2.25352

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