FDA Drug Safety Communication: Dolutegravir (Juluca©, Tivicay©, Triumeq©)

The U.S. Food and Drug Administration (FDA) is advising 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, which is used to treat human immunodeficiency virus (HIV). Approved in 2013, dolutegravir has been on the market for five years, and is available as a single ingredient product under the brand name Tivicay, and as a fixed dose combination tablet with other HIV medicines under the brand names Juluca and Triumeq.

Preliminary results from an ongoing observational study 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. To date, there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. The FDA is investigating this new safety issue and will update the public when more information is available.

This document contains references to brand name prescription medicines that are trademarks or registered marks of pharmaceutical manufacturers that are not affiliated with Horizon Blue Cross Blue Shield of New Jersey or the Blue Cross and Blue Shield Association.