Details
Based on preliminary results from an observational study suggesting a higher risk of neural tube defects among offspring of pregnant women using dolutegravir (see the FDA Drug Safety Communication below), FDA conducted a descriptive analysis of the prevalence and timing of dolutegravir use among HIV-infected women of childbearing age and HIV-infected women who had pregnancies with live birth deliveries. Prevalence of dolutegravir use among HIV-infected women of childbearing age was substantial, but the absolute number of dolutegravir-exposed pregnancies was very low. Although there was insufficient product exposure in pregnant women to support a robust safety assessment and the Sentinel mother-infant linkage was not yet available, the Sentinel analysis provided broader context regarding dolutegravir use among HIV-infected women who are of childbearing age or who had pregnancies with live birth deliveries.