An ongoing study in Botswana found that HIV-positive women who used dolutegravir when they became pregnant or early in their first trimester were more likely to have a baby with neural tube birth defects affecting the brain, spine, or spinal cord, such as spina bifida.
There are no reports of babies who were born with neural tube birth defects among women who used dolutegravir later in the pregnancy.
Dolutegravir is an anti-retroviral medicine that is sold alone (Tivicay®) or in combination with other medicines (Juluca® and Triumeq®).
It works by blocking an HIV enzyme to prevent the virus from multiplying, which can help reduce the amount of HIV in the body.
The FDA is asking pregnant women to talk to their doctor about switching to another HIV medication. Left untreated, HIV viruses could increase and spread to their unborn baby.
Neural tube defects happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their health care professional about other non-dolutegravir-containing antiretroviral medicines.”
The FDA is conducting a comprehensive review of the study and any other data that becomes available. The agency will also update the public with any new information.