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.
Result(s) (1)Dolutegravir Use During Pregnancy
Regulatory Link(s) (1)FDA Safety Communication
Related Publication(s) and/or Presentation(s) (1)Presentation: Dolutegravir Use Among Women of Child-Bearing Potential and During Early Pregnancy