FDA issues MedWatch safety alert for dolutegravir

FDA issued a MedWatch safety alert for antiretroviral drug dolutegravir in which the agency stated that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir for HIV infection.

FDA said preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the start or early in pregnancy were at higher risk for neural tube defects. There were no reports of these defects in babies born to women starting dolutegravir later in their pregnancy...