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TIVICAY, TRIUMEQ and JULUCA (dolutegravir containing medicines) – Possible Risk of Neural Tube Defects

Issued June 7, 2018
Issue
Serious cases of neural tube defects (NTD) in infants born to women with exposure to dolutegravir at the time of conception were identified in the ongoing observational study in Botswana. In the same study, no infant born to a woman who started dolutegravir during pregnancy had neural tube defects.
Hazard description
Product safety