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Dolutegravir use may carry a potential risk for neural tube birth defects in women using the drug at the time of conception or in early pregnancy. Evidence of this potential risk comes from preliminary results of an ongoing observational study in Botswana. Neural tube defects (eg, defects of the brain, spine, and spinal cord) were only seen in babies born to women who used dolutegravir at the time of conception or during the first pregnancy trimester. No cases of neural tube defects were seen when women started dolutegravir during later pregnancy. Dolutegravir is an antiviral FDA approved to treat human immunodeficiency virus (HIV). It is available as a single agent (brand name: Tivicay), as well as in combination with other drugs used to treat HIV (brand names: Juluca and Triumeq).
FDA is still investigating this new issue and will provide an update once more information is available. Do not stop dolutegravir without consulting with the prescriber. Stopping dolutegravir may result in worsening of the HIV infection. In pregnant women, this may also increase the risk of spreading the virus to the baby. Women of child-bearing potential should discuss with their provider using HIV regimens that do not include dolutegravir or use effective birth control if taking a dolutegravir-containing regimen. Women who are pregnant or planning pregnancy should discuss starting HIV regimens that do not include dolutegravir. Health care professionals should consider the risks and benefits of starting dolutegravir-containing regimens in women of childbearing potential and educate them about the potential risk of neural tube defects if starting a dolutegravir-containing regimen. Reinforce the importance of effective birth control in women starting a dolutegravir-containing regimen. Perform a pregnancy test in women of childbearing age prior to starting a dolutegravir-containing regimen. Report pregnancy exposures to dolutegravir to the Antiretroviral Pregnancy Registry at 1-800-258-4263.
Additional Information:
- FDA MedWatch Safety Report – May 18, 2018
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608168.htm - FDA Drug Safety Communication – May 18, 2018
www.fda.gov/Drugs/DrugSafety/ucm608112.htm