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On May 18, 2018, the FDA warned patients and doctors that certain medications used to treat the human immunodeficiency virus (HIV) may be linked to an increased risk of neural tube birth defects. Women who take these drugs before or during the first trimester may be more likely to give birth to babies with spina bifida or other types of similar defects.

The FDA is continuing to investigate this safety issue and will update the public as it receives new information. Meanwhile, women are advised to talk to their doctors about the risks.

HIV Drug Dolutegravir Linked with Increased Risk of Neural Tube Birth Defects

The FDA noted that preliminary results from an ongoing study found that women who received “dolutegravir”—the HIV medication in Juluca, Tivicay, and Triumeq—in early pregnancy appeared to be at a higher risk for neural tube birth defects. Taking the drug later in pregnancy didn’t seem to create the same risk.

Dolutegravir is an antiviral medication that works by blocking an HIV enzyme in the body called “integrase.” This helps prevent the virus from multiplying and causing acquired immunodeficiency syndrome (AIDS) and also helps reduce the risk of HIV transmission. The drug doesn’t cure HIV, but it does allow patients to live longer, healthier lives.

Three brand-name drugs include dolutegravir, including the following. All are manufactured by Viiv Healthcare.

  • Tivicay: FDA-approved in 2013, this is a single-ingredient medicine used in combination with other medications to treat HIV.
  • Triumeq: FDA-approved in 2014, this is a two-ingredient medicine that includes both dolutegravir and rilpivirine, and is used to treat HIV.
  • Juluca: FDA-approved in 2017, this is a three-ingredient medicine that includes dolutegravir, abacavir, and lamivudine, and is used to treat HIV.

Since all of these drugs include dolutegravir, they may increase the risk of neural tube birth defects.

Neural Tube Birth Defects Can Result in Long-Term Disability

Neural tube birth defects affect the brain, spine, and spinal cord. They occur when something damages the neural tube during the first few months of life. The neural tube is a small flat ribbon-shaped piece of tissue that later develops into the brain, vertebrae, tissues, and nerves. If something damages this tube, these structures may not form correctly, which can result in a child born with a variety of birth defects.

Spina bifida is the most common neural tube birth defect. This condition occurs when the neural tube doesn’t close like it should. It may cause paralysis in the legs, learning disability, spinal problems, difficulty controlling the bowel and bladder, and fluid buildup on the brain.

More rare types of neural tube birth defects include anencephaly and iniencephaly, both of which are typically fatal within a few hours of birth, and encephalocele, which results in the brain protruding through an underdeveloped skull.

FDA Suggests Women Talk to Their Doctors

The FDA warns that neural tube birth defects usually occur very early on in pregnancy, often before women know they’re pregnant. As such, women of childbearing age are urged to talk to their doctors about these medications. Women taking these medications should also make sure to consistently use birth control.

The FDA also advised healthcare providers to discuss the risks and benefits with women before prescribing these drugs, and to consider alternative treatments.

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