US, EU Warn About Birth Defect Risk from Dolutegravir

May 21, 2018

(Medscape) – The US Food and Drug Administration (FDA) and the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) have warned that women with HIV who take dolutegravir (Tivicay, GlaxoSmithKline) at the time of conception or during the first trimester of pregnancy appear to be at higher risk of giving birth to infants with neural tube defects, including spina bifida.