MAY 18, 2018

FDA Warns of Neural Tube Birth Defects With Dolutegravir

By IDSE News Staff

The FDA issued an alert about serious cases of neural tube birth defects involving the brain, spine and spinal cord that have been reported in babies born to women treated with dolutegravir used to treat HIV.

Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.