Juluca, Tivicay, Triumeq (Dolutegravir) Lawsuit

Filing a Juluca, Tivicay, or Triumeq lawsuit may be an option for families whose children suffered a neural tube birth defect following first-trimester exposure to any of these dolutegravir-containing HIV medications.

Contact an Attorney for a Free Review of Your Juluca, Tivicay or Triumeq Lawsuit

The nationwide law firm of Bernstein Liebhard LLP is investigating dolutegravir lawsuits on behalf of families whose children were born with neural tube defects possibly associated with their mother’s use of Juluca, Tivicay, or Triumeq in the first trimester of pregnancy.

If you took a dolutegravir-containing medication during the first three months of your pregnancy, and gave birth to a child with spina bifida, anencephaly, or Chiari malformation, please contact our office as soon as possible.

Free, confidential and no-obligation legal consultations can be arranged by calling (888) 994-5118.

Juluca, Tivicay & Triumeq

The integrase inhibitor (INSTI) dolutegravir is indicated to treat HIV in adults and children over 12 who weigh at least 88 lbs. The medication was first approved by the U.S. Food & Drug Administration in 2013 as the brand-name drug Tivicay.

Triumeq, a combination of dolutegravir, abacavir and lamivudine, was cleared for sale the following year.

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

Dolutegravir: What’s the Problem?

In May 2018, the FDA disclosed that it was investigating serious cases of neural tube birth defects involving the brain, spine, and spinal cord that had been reported in babies born to women who were treated with dolutegravir-containing drugs.

Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir when they became pregnant or early in the first trimester are at higher risk for these defects. There were no reports of neural tube birth defects among women who started taking dolutegravir later in pregnancy.

The FDA is continuing to investigate neural tube birth defects possibly associated with Tivicay, Triumeq, and Juluca. The agency indicated that it would update the public when it has gathered additional information.

In the meantime, the FDA has advised women to let their doctor know if they are pregnant or are planning to become pregnant before starting a dolutegravir-containing regimen. Women being considered for dolutegravir should also undergo a pregnancy test before beginning treatment.

Women of child-bearing age who take Juluca, Tivicay, or Triumeq should be sure to use an effective birth control method while undergoing treatment.

For those who are already pregnant, stopping a dolutegravir-containing regimen without switching to an alternative HIV medicine could cause the amount of virus to increase and spread HIV to the baby.

What are Neural Tube Birth Defects?

Neural tube defects are birth defects of the brain, spine, or spinal cord that occur early in the first trimester of pregnancy, often before a woman even knows that she is pregnant.

Spina bifida and anencephaly are the most common neural tube defects. Spina bifida occurs when the fetal spinal column fails to close completely.

In anencephaly, most of the brain and skull do not develop. Babies with anencephaly are usually either stillborn or die shortly after birth.

Another type of neural tube defect, Chiari malformation, causes the brain tissue to extend into the spinal canal.

Was Your Child Born with a Neural Tube Birth Defect that May be Associated with Juluca, Triumeq, or Tivicay? Contact Our Attorneys Today.

Your family could be entitled to significant financial compensation if your child was born with a neural tube birth defect following first-trimester exposure to dolutegravir.

To learn if you are eligible to file a Juluca, Triumeq or Tivicay lawsuit, please contact our office at (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. Medline Plus (N.D.) “Neural Tube Birth Defects” https://medlineplus.gov/neuraltubedefects.html
Last Modified: May 31, 2018

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