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On May 18, 2018, the FDA warned patients and physicians that certain drugs used to treat the human immunodeficiency virus (HIV) could be linked to an increased risk of birth defects . Women taking these medications before or during the first trimester may be more likely to give birth to babies with spina bifida or other similar types of defects.
The FDA continues to study this safety issue and update the public as soon as it receives new information. During this time, women are advised to talk to their doctors about their risks.
Dolutegravir badociated with increased risk of conbad malformations of the gastrointestinal tract
The FDA noted that preliminary results from an ongoing study showed that women were receiving dolutegravir. -Juluca, Tivicay and Triumeq-HIV treatment in early pregnancy seemed to be at a higher risk of conbad neural tube defects. Taking the drug later during pregnancy did not seem to create the same risk.
Dolutegravir is an antiviral drug that works by blocking an HIV enzyme called integrase. This prevents the virus from multiplying and causes acquired immunodeficiency. syndrome (AIDS) and also helps reduce the risk of HIV transmission. The drug does not cure HIV, but it allows patients to live longer and healthier lives.
Three brand name drugs include dolutegravir, including the following. All are manufactured by Viiv Healthcare
- Tivicay: approved by the FDA in 2013, it is a single ingredient drug used in combination with other drugs to treat HIV .
- Triumeq: approved by the FDA 2014, it is a two-ingredient drug that includes both dolutegravir and rilpivirine, and is used to treat HIV.
- Juluca: approved by the FDA in 2017, it is a drug with three ingredients including dolutegravir, abacavir, and lamivudine, and is used to treat the HIV
As all of these drugs include dolutegravir, they may increase the risk of conbad malformations of the neural tube.
Conbad malformations of the neural tube may result in long-term disability
Conbad tube defects affect the brain, spine and spinal cord. They occur when something damages the neural tube during the first months of life. The neural tube is a small piece of ribbon-shaped tissue that develops later in the brain, vertebrae, tissues, and nerves. If something damages this tube, these structures may not form properly, which can result in a child born with a variety of birth defects.
Spina bifida is the most common conbad malformation of the neural tube. This condition occurs when the neural tube does not close as it should. It can cause paralysis of the legs, learning difficulties, spinal problems, difficulty in controlling the intestines and bladder and fluid accumulation in the brain.
Anencephaly and intipepphritis are more rare types of conbad malformations. in a few hours of birth, and encephalocele, resulting in the brain protruding through an underdeveloped skull.
FDA suggests women talk to their doctors
The FDA warns that birth defects in the neural tube usually occur very early in pregnancy, often women know that they are pregnant. As such, women of childbearing age are encouraged to talk to their doctors about these medications. Women taking these medications should also make sure to always use birth control.
The FDA also advises health professionals to discuss risks and benefits with women before prescribing these drugs and considering other treatments.
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