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.
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.
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.
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:
Headache – especially after coughing, sneezing, or straining – is a primary symptom of Chiari malformation.
Other symptoms may include:
Infants with Chiari malformation may exhibit:
Chiari malformation is often associated with other conditions, including:
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:
To learn more about filing a dolutegravir lawsuit, please contact our office by calling: (888) 994-5118.
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