the safety of aripiprazole in question

United States – According to a birth cohort study conducted from two American databases, bringing together more than 3.4 million children followed for 14 years, there is an increased risk of neurodevelopmental disorders if children are exposed to antipsychotics during pregnancy, but this would not be the case Case his no longer be significant after considering several factors that may affect the child’s prognosis, with the exception of aripiprazole [1].

With regard to aripiprazole, no cause could be suggested from the post hoc analyzes and no causality was demonstrated by this work. Further studies would therefore be necessary.

Why is that important?

Antipsychotics are lipophilic and can therefore cross the placenta. Animal data suggest potential neurotoxic properties, but data on teratogenic effects on the developmental nervous system in humans are sparse. This requires long-term longitudinal studies on exposure. in utero to antipsychotics and the diagnosis of childhood neurodevelopmental disorders (NDDs), and further complicated by the many potential confounders. This large epidemiological study, conducted over a 14-year period, proposes to assess the relationship between exposure in utero to antipsychotics and NDTs through the integration of multiple confounders.

These results are helpful to better assess the benefit-risk ratio in the care of pregnant women with mental illnesses and to regularly monitor the neurological development of their children.

methodology

Two databases were used in this study (Medicaid Analytic eXtract or MAX 2000-2014 and MarketScan 2003-2015).

The authors analyzed two exposure periods: first the second half of pregnancy (> 18 weeks), which corresponds to the period of synaptogenesis, then the first half as part of the secondary analyzes given the uncertainty about the mechanisms that might be involved. Children were considered exposed if their mother had been prescribed an antipsychotic during the period under review.

The neurodegenerative disorders sought during follow-up were those most commonly diagnosed in the United States, namely: Autism Spectrum Disorders, Attention Deficit/Hyperactivity Disorder, Learning Disabilities, Language or Developmental Language Disorders, Developmental Coordination Disorders, Intellectual Disabilities, Behavioral, Behavioral and emotional disorders.

Principle results

A total of 2,034,883 and 1,306,408 children from the MAX and MarketScan cohorts who were unexposed during the prenatal period were compared to 9,551 and 1,221 children, respectively. The majority of these exposures were to atypical antipsychotics (about 90% across the two cohorts and the two assessment periods), mainly quetiapine (about 40%) and then aripiprazole (16-23%).

At 8 years of age, data from the MAX database show that the cumulative incidence of children with a diagnosis of TND was 37.3% for those exposed in the second half of pregnancy compared to 23.7% for those exposed those who weren’t. According to the MarketScan database, they were at 24.5% versus 11.0%. The TND risk did not increase significantly after adjustment (unadjusted HR 1.91 [1,79-2,03] vs HR adjusted 1.08 [1,01-1,17]), with the exception of aripiprazole (1.36 [1,14-1,63]). Sensitivity and subgroup analyzes did not change the conclusions.

In the children of mothers who took aripiprazole during the second trimester of pregnancy, the main risks were speech and language disorders and behavioral disorders. An increased risk was also observed with exposure during the first half of pregnancy.

This article was originally published on Univadis.fr, member of the Medscape network.

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