Dolutegravir (Tivicay and Combination Products Juluca, Triumeq) & Exposure in Pregnancy

Basic Details
Status
Complete
Last Updated
Thursday, March 28, 2019
Health Outcome(s)
exposure in pregnancy
Purpose
Drug Use
Regulatory Determination / Use

FDA assessed the feasibility of conducting a postmarket study in Sentinel to further investigate preliminary results from an observational study suggesting a higher risk of neural tube defects among offspring of pregnant women using dolutegravir (see the related FDA Drug Safety Communication below). The Sentinel query identified insufficient product exposure in pregnant women to support a robust safety assessment.