Drugs

FDA Drug Safety Podcast: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On May 18, 2018, FDA alerted 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 treated with dolutegravir used to treat human immunodeficiency virus (or HIV). 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.

To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. Dolutegravir is an FDA-approved antiretroviral medicine used in combination with other antiretroviral medicines to treat HIV, the virus that can cause acquired immunodeficiency syndrome (or AIDS). 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 (active ingredients dolutegravir and rilpivirine) and Triumeq (active ingredients abacavir, dolutegravir, and lamivudine).

Health care professionals should inform women of childbearing age about the potential risk of neural tube defects when a dolutegravir-containing regimen is used at the time of conception and early in pregnancy. In addition:

  • Health care professionals should weigh the benefits and the risks of dolutegravir when prescribing antiretroviral medicines to women of childbearing age. Alternative antiretroviral medicines should be considered. Discuss the relative risks and benefits of appropriate alternative antiretroviral therapies.
  • If the decision is made to use dolutegravir in women of childbearing age, health care professionals should reinforce the consistent use of effective birth control.
  • Perform pregnancy testing before initiating a dolutegravir-containing regimen in women of childbearing age to exclude pregnancy.

Ongoing monitoring will continue as part of the observational study in Botswana. We will update the public with any new information. To monitor birth outcomes of pregnant women, report pregnancy exposures to the Antiretroviral Pregnancy Registry at 1-800-258-4263.

Report side effects involving dolutegravir to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing information for health care professionals can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov

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Page Last Updated: 05/24/2018
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