Juluca, Tivicay, Triumeq Linked to Anencephaly

The HIV medications Juluca, Tivicay, and Triumeq have been linked to anencephaly, a neural tube birth defect that causes a baby to be born without part of the brain and skull.

Concerned that Juluca, Tivicay or Triumeq Caused Your Baby’s Anencephaly? Contact Our Office Today for a Free Legal Review.

The nationwide law firm of Bernstein Liebhard LLP is investigating incidents of anencephaly and other neural tube defects that may be associated with prenatal exposure to Juluca, Tivicay or Triumeq. To obtain a free, no-obligation review of your potential claim, please call (888) 994-5118.

 FDA Investigating Reports of Neural Tube Defects Linked to Dolutegravir

Tivicay (dolutegravir) was approved by the U.S. Food & Drug Administration (FDA) in 2013 to treat HIV in adults and children over the age of 12 who weigh at least 88 lbs.

The combination drug, Triumeq (dolutegravir, abacavir and lamivudine), was approved in 2014 to treat adults for the maintenance treatment of virologically suppressed HIV-1 infection.

In 2017, the FDA approved Juluca (dolutegravir and rilpivirin) for use in adults for the maintenance treatment of virologically suppressed HIV-1 infection.

In May 2018, preliminary results from a study conducted in Botswana indicated that women taking dolutegravir when they became pregnant or in the first trimester of pregnancy were more likely to give birth to a child with neural tube defects, including anencephaly. There were no reports of neural tube defects among women who began taking dolutegravir-containing drugs later in pregnancy.

The findings prompted the FDA to issue a public health alert and begin a review of Juluca, Tivicay, and Triumeq. Among other things, the agency is advising that:

  • Women who are pregnant or planning to become pregnant should inform their healthcare provider prior to beginning treatment with Juluca, Tivicay, or Triumeq.
  • Women of child-bearing age should undergo a pregnancy test before they begin treatment with any dolutegravir-containing medication.
  • Women who become pregnant while using Juluca, Tivicay or Triumeq should talk with their doctors, as ending their treatment regimen without switching to an alternative HIV medicine could cause the amount of virus to increase and spread HIV to the baby.

What is Anencephaly?

The upper part of the neural tube helps form a baby’s brain and skull during the first weeks of pregnancy.

Anencephaly occurs when the upper part of the neural tube fails to close completely. This may result in a baby being born without the forebrain (front part of the brain) or the cerebrum (coordinated part of the brain. The remaining parts of the brain may not be covered by bone or skin.

According to the U.S. Centers for Disease Control and Prevention (CDC), anencephaly affects 3 pregnancies of every 10,000 that occur annually in the United States, or roughly 1,206 pregnancies per year.

Anencephaly is often diagnosed before birth via prenatal screening. However, the condition will be immediately apparent upon birth if it was not previously diagnosed.

Sadly, there is no treatment for anencephaly, and most patients born with this condition will die shortly after birth.

Lear More about Filing a Juluca, Tivicay or Triumeq Lawsuit for Anencephaly.

Our defective drug attorneys are investigating Juluca, Tivicay, and Triumeq lawsuits for anencephaly and other neural tube birth defects. To learn more, and to obtain a free review of your case, please contact our office by calling: (888) 994-5118.

  1. FDA (N.D.) “Tivicay: Highlights of Prescribing Information” https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf
  2. FDA (2014) “Triumec: Highlights of Prescribing Information” https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205551s000lbl.pdf
  3. FDA (2017) “Juluca: Highlights of Prescribing Information” https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204790s014lbl.pdf
  4. FDA (2018) “FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)” https://www.fda.gov/Drugs/DrugSafety/ucm608112.htm
  5. CDC (2017) “Facts About Anencephaly”” https://medlineplus.gov/neuraltubedefects.html
Last Modified: June 6, 2018

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