Medication Monitor

Generic Name (Trade Name—Company)
May 23, 2018


(Tivicay—ViiV Healthcare)
FDA evaluating potential risk of neural tube birth defects with HIV med

FDA is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women who took dolutegravir for HIV treatment.

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.

Dolutegravir is an FDA-approved antiretroviral medicine used in combination with other antiretroviral medicines to treat HIV/AIDs. Dolutegravir works by blocking integrase, an HIV enzyme, to prevent the virus from multiplying and can reduce the amount of HIV in the body. 

Approved in 2013, dolutegravir has been on the market for 5 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.

Ongoing monitoring will continue as part of the observational study in Botswana. Additional birth outcomes are projected from pregnant women who were exposed to dolutegravir at the time of becoming pregnant. 

To date, this observational study has found no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. FDA is investigating this new safety issue and will update the public when it has more information.

To monitor birth outcomes of pregnant women, report pregnancy exposures to the Antiretroviral Pregnancy Registry at 800-258-4263.