Integrase inhibitor drugs during pregnancy and congenital anomalies: A case/non‐case study from the global pharmacovigilance database VigiBase

In 2018, a significant neural tube defects (NTD) signal was reported after pre‐conceptional exposure to dolutegravir, but was not confirmed in further analysis. Since 2019, dolutegravir‐based regimen, an integrase inhibitor (INI), is recommended by WHO as the most‐effective first‐line therapy in all...

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Bibliographic Details
Published in:Pharmacology research & perspectives 2024-08, Vol.12 (4), p.e1247-n/a
Main Authors: Saint‐Lary, Laura, Lacroix, Isabelle, Leroy, Valériane, Sommet, Agnès
Format: Article
Language:English
Subjects:
Abnormalities, Drug-Induced - epidemiology
Adolescent
Adult
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Antiretroviral drugs
Birth defects
Case studies
case/non‐case study
Child
Child, Preschool
congenital anomalies
Congenital diseases
Databases, Factual
Dictionaries
Drug dosages
Female
Genetic disorders
Heterocyclic Compounds, 3-Ring - adverse effects
Heterocyclic Compounds, 3-Ring - therapeutic use
High income
HIV
HIV Infections - drug therapy
HIV Integrase Inhibitors - adverse effects
HIV Integrase Inhibitors - therapeutic use
Human immunodeficiency virus
Humans
Infant, Newborn
integrase inhibitors
Life Sciences
Middle Aged
Original
Oxazines - adverse effects
Pharmaceutical sciences
Pharmacology
Pharmacovigilance
Piperazines - adverse effects
Population
Pregnancy
Pregnancy Complications, Infectious - drug therapy
Prenatal exposure
Pyridones - adverse effects
Quinolones
Raltegravir Potassium - adverse effects
Raltegravir Potassium - therapeutic use
Santé publique et épidémiologie
Side effects
Womens health
Young Adult
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Summary:In 2018, a significant neural tube defects (NTD) signal was reported after pre‐conceptional exposure to dolutegravir, but was not confirmed in further analysis. Since 2019, dolutegravir‐based regimen, an integrase inhibitor (INI), is recommended by WHO as the most‐effective first‐line therapy in all patients living with HIV. To explore the potential INI‐related teratogenic effect, we searched disproportionate signals between exposure to INI‐class drugs and congenital anomalies, compared to non‐INI drugs, using the international pharmacovigilance database, VigiBase®. We selected all the reports registered in VigiBase® between 01/01/2007 and 30/03/2021 on any antiretroviral drug‐related fetal or neonatal adverse drug reactions, declared either in children (
ISSN:2052-1707
2052-1707
DOI:10.1002/prp2.1247