HIV Medication Dolutegravir Linked to Neural Tube Defects in Infants
The United States Food and Drug Administration (FDA) released a warning to pregnant women about the risks of infants being born with neural tube defects if they are exposed to dolutegravir while in vitro, especially during early pregnancy. The dolutegravir study, on which the FDA based its warning, was conducted in Botswana where researchers had observed higher rates of neural tube defects in babies born to women who had been taking dolutegravir when they became pregnant, or early on in their pregnancies.
What is Dolutegravir?
Dolutegravir is an antiretroviral medication that is used to treat HIV, the virus that can lead to AIDS. The medicine is typically prescribed along with other forms of antiretroviral drugs. Dolutegravir is sold under several brand names, including Tivicay, Juluca, and Triumeq. The drug is sold alone in Tivicay and as a combination of medications in the other forms, Juluca and Triumeq.
Dolutegravir blocks an HIV enzyme called integrase. By blocking the enzyme, the medication works to lower the amount of the virus in a person’s system.
Dolutegravir was first approved by the FDA in 2013 and has been prescribed for about five years now.
What is a Neural Tube Defect?
Neural tube defects are a form of congenital disabilities that impact the infant’s spine, spinal cord, and brain. One of the problems with this kind of defect is that it tends to occur very early in a woman’s pregnancy. Neural tube defects happen in the first month of pregnancy, and as a result, many women do not even know that they are pregnant by the time the defect has occurred.
Once a fetus has developed this form of defect, there is no cure. There are sometimes ways to prevent further damage or to manage some of the complications caused by the defect.
Spina bifida and anencephaly are the most common forms of neural tube defects. Infants born with spina bifida have spinal cords that fail to close properly. As a result, the infants experience varying degrees of paralysis of the legs. Some babies born with spina bifida may be able to walk some with an aid like braces or crutches, while others might require a wheelchair. These individuals may experience other complications as well, including problems with their urinary tracts or bowels, and learning disabilities.
Anencephaly causes problems with the development of the brain and the skull. Most babies born with this severe form of the defect are stillborn or die not long after they are born.
While the exact cause of neural tube defects is still unknown, but the condition seems more prevalent in women who are obese, suffer from poorly controlled diabetes, and who take certain medications for seizures, and women who take Dolutegravir.
Doctors recommend that pregnant women get enough folic acid during their pregnancies as this can often prevent neural tube defects.
What if I am Pregnant and Taking Dolutegravir?
According to the FDA, women who are taking any form of Dolutegravir should not stop the medication without first consulting with their physicians. If you have HIV and stop taking this antiretroviral medication, you could increase the amount of the virus in your system. This could not only impact your health, but it could also increase the chances of the virus being passed to your baby. If you have concerns, speak to your doctor right away.
If you are on Dolutegravir and considering becoming pregnant, you should speak to your doctor before trying to get pregnant so that you can weigh the risks and benefits of the medication and discuss alternative options. If you are planning to start taking this drug, talk to your doctor about whether you are planning to get pregnant, and take a pregnancy test before starting the medication. While on Dolutegravir, you should be using an effective form of birth control.
The FDA also says that doctors should be cognizant of the risks presented by this drug and how it could impact infants. Doctors should explain the risks to their patients and be sure that they are not prescribing the medication to someone who is pregnant or planning a pregnancy.
Research is Ongoing
The study linking Dolutegravir to birth defects is relatively new. The FDA has stated that they are continuing to investigate the possible risks of this medication and that they will provide updates as more information is known.
Dolutegravir Lawsuit Claims
Defective drug lawsuits are a form of product liability claims. Product liability claims are the result of defective products. If a company manufactures or sells a product that is dangerous and that causes injuries to consumers, that company can be held liable and be required to compensate injured people for the harm that was done to them.
Products can be designed defectively, be defective as a result of a manufacturing error, or can be defective because the company marketed the product for the wrong purpose or failed to warn consumers about the product’s risks.
Defective medications can cause severe injuries or even death. Medications could be defective because they have side-effects that make them dangerous, in which case, they are designed defectively. There are also times when medications are manufactured with the wrong amounts of active ingredients, or when they become contaminated. This would be a good example of a manufacturing defect. Finally, sometimes medications are defective because they were marketed towards a population that should not be taking the medication or because of a failure to warn of known risks. If a company fails to warn pregnant women not to take a medication that is dangerous to fetuses, this would be a marketing or warning defect.
The Statute of Limitations on Dolutegravir Lawsuits
A statute of limitations limits the amount of time an injured person has to file their lawsuit against the party that caused them harm. The amount of time allotted varies by state, but every state has a statute of limitations. This is why it is essential to speak with an attorney as soon as you believe that you might have a claim.
Parker Waichman LLP has decades of experience handling cases in the specific and complex area of defective drug liability. Our firm has recovered more than $2 billion in compensation for our clients.
Contact us today at 1-800-YOURLAWYER (1-800-968-7529) for a free consultation with one of our Dolutegravir lawsuit attorneys.
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