Juluca, Tivicay, and Triumeq Linked to Chiari Malformation

Women who take dolutegravir-containing HIV drugs, including Juluca, Tivicay, and Triumeq, during the first trimester of pregnancy may be more likely to have a child with a Chiari malformation or other neural tube birth defects.

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

The nationwide law firm of Bernstein Liebhard LLP is investigating incidents of Chiari malformation 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 Launches Dolutegravir Review in Response to Botswana Birth Defects Study

Tivicay, known generically as dolutegravir, received U.S. Food & Drug Administration (FDA) approval in 2013. It is currently indicated to treat HIV in adults and children over 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.

The FDA began reviewing a possible association between dolutegravir and neural tube defects in May 2018, after early results from a study conducted in Botswana suggested that women who used the drug when they became pregnant or during their first trimester of pregnancy were more likely to give birth to a child with neural tube birth defects.

While its review is ongoing, the agency is advising women of child-bearing age to undergo a pregnancy test before starting treatment with Juluca, Tivicay, or Triumeq. They should also use a reliable method of birth control while taking any dolutegravir-containing medication.

Women who are pregnant or planning to become pregnant should inform their healthcare provider prior to beginning treatment with Juluca, Tivicay, or Triumeq.

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 Chiari Malformation?

Chiari malformations are structural defects in the base of the skull and cerebellum, the part of the brain that controls balance.

There are four types of Chiari malformation:

  • Chiari malformation Type 1 occurs when the lower part of the cerebellum (called the cerebellar tonsils) extends into the foramen magnum. Type 1 is the most common form of Chiari malformation. It may not cause symptoms, although adolescents and adults may develop symptoms later in life.
  • Chiari malformation Type II occurs when the cerebellum and brain stem tissue protrude into the foramen magnum. The nerve tissue that connects the two halves of the cerebellum may also be missing or only partially formed. Type 2 is usually accompanied by a myelomeningocele, the most severe form of spina bifida. This disorder can cause life-threatening complications during infancy or early childhood, and treating it requires surgery.
  • Chiari Malformation Type III occurs when some of the cerebellum and the brain stem stick out, or herniate, through an abnormal opening in the back of the skull.  This can also include the membranes surrounding the brain or spinal cord. This is the most serious type of Chiari malformation. Symptoms appear in infancy and can cause debilitating and life-threatening complications.
  • Chiari Malformation Type IV occurs when the cerebellum is located in the normal position but parts of it are missing. Portions of the skull and spinal cord may be visible.

Chiari Malformation Symptoms

Headache – especially after coughing, sneezing, or straining – is a primary symptom of Chiari malformation.

Other symptoms may include:

  • Neck pain
  • Hearing or balance problems
  • Muscle weakness or numbness
  • Dizziness
  • Difficulty swallowing or speaking
  • Vomiting
  • Ringing or buzzing in the ears (tinnitus)
  • Curvature of the spine (scoliosis)
  • Insomnia
  • Depression
  • Problems with hand coordination and fine motor skills.

Infants with Chiari malformation may exhibit:

  • Difficulty swallowing
  • Irritability when being fed
  • Excessive drooling
  • A weak cry
  • Gagging or vomiting
  • Arm weakness
  • Stiff neck
  • Breathing problems
  • Developmental delay
  • Inability to gain weight

Chiari Malformation Complications

Chiari malformation is often associated with other conditions, including:

  • Hydrocephalus or an excessive buildup of cerebral spinal fluid. Most commonly associated with Type 2.
  • Spina bifida
  • Syringomyeliais a disorder in which a fluid-filled tubular cyst, or syrinx, forms within the spinal cord’s central canal.
  • Tethered cord syndrome occurs when a child’s spinal cord abnormally attaches to the tissues around the bottom of the spine, preventing the spinal cord from moving freely within the final canal.
  • Spinal curvature is common among individuals with syringomyelia or Chiari malformation Type I.

Learn More about Filing a Juluca, Tivicay or Triumeq Lawsuit

If your child was born with a Chiari malformation 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) “Triumeq: 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. NIH (2017) “Chiari Malformation Fact Sheet” https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Chiari-Malformation-Fact-Sheet
Last Modified: June 7, 2018

Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.


Follow Us

RXInjuryHelp.com on Google+  RXInjuryHelp.com on Facebook  RXInjuryHelp.com on LinkedIn  RXInjuryHelp.com on Twitter  RXInjuryHelp.com on YouTube  RXInjuryHelp.com on Pinterest

Skip to content