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

    Basic Details
    Last Updated
    Thursday, March 28, 2019
    Health Outcome(s)
    exposure in pregnancy
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    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.