Neural Tube Birth Defect Risk Linked to Juluca, Tivicay, Triumeq: FDA Warns

Federal regulators warn that some HIV drugs, including Juluca, Tivicay and Triumeq, have been linked to serious cases of neural tube birth defects when used by pregnant women. 

In a drug safety communication issued on May 18, the FDA warns that unborn children’s brains, spines and spinal cords may not develop properly when expecting mothers use drugs with the active ingredient dolutegravir.

The warning comes from the preliminary results of an ongoing observational study involving dolutegravir in Botswana. After seeing those results, the FDA has launched a safety investigation into drugs that use dolutegravir, including Juluca, Tivicay and Triumeq.

The FDA first approved dolutegravir in 2013. It is an antiretroviral medication which is used with other HIV drugs. It blocks an HIV enzyme known as integrase to prevent HIV from multiplying. Sold alone under the brand name Tivicay, it is also sold as a combination drug as Juluca and Triumeq.

The agency warned that neural tube birth defects happen early in pregnancy, often before women even know they are pregnant. This makes it important that women be aware of the risks before they begin to drug, to prevent potential exposure during the first trimester. The FDA issued recommendations for health care professionals and patients while it conducts its review.

For patients, it called for women to tell their health care professional if they are pregnant or planning to become pregnant before starting a drug treatment regimen including dolutegravir. The agency also recommends all women of childbearing age who take Tivicay or other dolutegravir-containing drugs consistently use an effective form of birth control while on the treatment.

The FDA also indicates all women should take a pregnancy test before beginning treatment with the drug.

However, the FDA also warns that women should not stop taking Tivicay or other dolutegravir-based drugs without first talking to their healthcare professional. If they are taking the drug, they should consult their doctor about switching to an alternative medication.

The FDA recommended that doctors inform women of child-bearing age about the potential risks, weigh the benefits and risks of the drug before prescribing it, reinforce consistent use of birth control when prescripbed to women, and perform pregnancy tests on all women of childbearing age before initiating a dolutegravir-based regimen.

The agency indicates that it is continuing to monitor the ongoing study in Botswana, and will conduct a comprehensive review of any data that becomes available. The FDA also asks women to report pregnancy exposures to the Antiretroviral Pregnancy Registry at 1-800-258-4263.