Juluca, Tivicay, and Triumeq Linked to Spina Bifida

The HIV drugs Juluca, Tivicay, and Triumeq have been linked to spina bifida and other neural tube birth defects when taken during the first three months of pregnancy.

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

The nationwide law firm of Bernstein Liebhard LLP is investigating incidents of spina bifida 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 Reviewing Dolutegravir and Neural Tube Birth Defects

Dolutegravir, the active ingredient in Juluca, Tivicay and Triumeq, was approved by the U.S. Food & Drug Administration (FDA) in 2013 under the brand name Tivicay. The drug is indicated for the treatment of HIV in adults, as well as children over the age of 12 who weigh at least 88 lbs.

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.

In May 2018, the FDA announced it was reviewing a possible association between neural tube defects, including spina bifida, and the use of Juluca, Tivicay, or Triumeq in the early months of pregnancy. The agency acted after preliminary results of a study conducted in Botswana found that women who receive dolutegravir-containing medications when they became pregnant or early in the first trimester are at higher risk for these abnormalities. There were no reports of neural tube birth defects among women who started taking dolutegravir later in pregnancy.

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 prior before taking any dolutegravir-containing HIV drug. Once they begin treatment, women in this group should be sure to use an effective birth control method while taking dolutegravir.

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

What is Spina Bifida?

Spina bifida is a condition in which a portion of the neural tube fails to develop or close properly, causing defects in the spinal cord and in the bones of the spine. Normally, the neural tube would close by the 28th day of pregnancy.

There are three main types of spina bifida:

  • Spina Bifida Occulta: A small separation or gap forms in one or more of the bones of the spine (vertebrae). This is the mildest form of spina bifida and many are unaware that they have it.
  • The meninges – protective membranes around the spinal cord – push out through the opening in the vertebrae, forming a fluid-filled sac. Because the sac doesn’t include the spinal cord, nerve damage is less likely. However, later complications are possible.
  • Myelomeningocele or Open Spina Bifida: The spinal canal is open along several vertebrae in the lower or middle back, forming a sac in which the membranes and spinal nerves are exposed. Because of this exposure, children with open spina bifida may suffer from physical and learning disabilities and are prone to life-threatening infections.

Spina Bifida Complications

In many cases, spina bifida causes only minor symptoms or disability. Severity depends on the location of the defect, whether the area is covered by skin, and whether spinal nerves are exposed.

Possible complications and disabilities that may occur with spina bifida include:

  • Walking and mobility problems
  • Orthopedic complications, including curved spine (scoliosis), abnormal growth or dislocation of the hip, bone and joint deformities, muscle contractures and other orthopedic concerns.
  • Bowel and bladder problems
  • Hydrocephalus (fluid on the brain)
  • Shunt malfunction
  • Chiari malformation
  • Infection in the meninges
  • Tethered spinal cord
  • Sleep disordered breathing
  • Skin problems
  • Latex allergy
  • Other complications: Urinary tract infections, gastrointestinal (GI) disorders, depression and learning disabilities.

Treatment for Spina Bifida

Treatment for spina bifida depends on the severity and type.

Children with spina bifida occulta usually require no treatment.

Surgery to treat the meningocele or myelomeningocele forms of spina bifida can take place before or after birth. Babies with myelomeningocele spina bifida may need more surgery for a variety of complications, as well as other ongoing care, including physical therapy, speech therapy, and special education.

Lear More about Filing a Juluca, Tivicay or Triumeq Lawsuit

If your child developed spina bifida due to Juluca, Tivicay or Triumeq, your family may be entitled to compensation for costs related to:

  • Medical treatments and equipment (wheelchairs, braces, etc.)
  • Ongoing care, including physical therapy and rehabilitation
  • Special education
  • Pain and suffering
  • Emotional distress
  • More

To learn more about filing a dolutegravir lawsuit, 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. Mayo Clinic (N.D.) “Spina Bifida” https://www.mayoclinic.org/diseases-conditions/spina-bifida/symptoms-causes/syc-20377860
Last Modified: June 5, 2018

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