By Scott Baltic
NEW YORK (Reuters Health) – The established benefits of aripiprazole for women with bipolar disorder or schizophrenia appear to outweigh the drug’s risks during pregnancy and lactation, according to a systematic literature search and review from Italy.
In their report, online December 13 in the Journal of Affective Disorders, the authors conclude that “the available information does not contraindicate maternal use of aripiprazole during pregnancy or lactation.” They nonetheless recommended that treatment decisions include a thorough risk-benefit analysis, based on the patient’s clinical history, ongoing treatment, and current symptoms.
The researchers evaluated 93 reports, published from 1995 to 2017, on aripiprazole use in pregnancy, the peripartum period, and during lactation. The reports included large prospective studies, large database studies, and several case reports and case studies – but no randomized trials (which are not conducted in this clinical setting for ethical reasons).
The new review assessed the published literature qualitatively but did no quantitative meta-analysis of the data. The article simply summarizes the literature, with the clinical studies categorized as follows: perinatal period; early and mid-pregnancy; late pregnancy and maternal, obstetric, and postnatal complications; fetal/neonatal adverse reactions; and lactation.
The review concludes that “the risk of adverse events in infants exposed to aripiprazole is low, and therefore the risks of withdrawing this medication during pregnancy should always be weighed against the risks of continuing it.”
Medication treatment during pregnancy can pose risks such as fetal malformation and neonatal complications, but untreated mental illness also can carry risks for the pregnant woman and her child, corresponding author Dr. Alessandro Cuomo, of the University of Siena School of Medicine, in Italy, told Reuters Health by email.
Because “the risks associated with the untreated mental disease often outweigh those associated with medication treatment,” he continued, “it is often necessary to treat the mental illness, whilst avoiding exposure of the child to riskier medication.”
Given its efficacy and relatively favorable tolerability, Dr. Cuomo noted, aripiprazole is frequently used by women with bipolar disorder or schizophrenia in their childbearing years.
Until recently, data on the use of aripiprazole during pregnancy were relatively limited, and even hinted at a need for caution. Now, however, the larger pool of existing data support the use of aripiprazole in women at high risk of dangerous relapses, Dr. Cuomo said, “especially when drugs with a larger safety database are not indicated” because of their side effects, the patient’s history of intolerance or nonresponse to those drugs, or the risks for relapse if a patient helped by aripiprazole switches from it to another medication.
“This is a nice paper, in that it pulls together a diverse literature and summarizes what is currently known about the safety of aripiprazole in pregnancy and lactation and includes both animal and human studies, as well as different periods of gestation,” Dr. Jennifer L. Payne, of Johns Hopkins School of Medicine, Baltimore, told Reuters Health by email.
In general, she said, women who take aripiprazole have a serious mental illness and are almost certain to have a relapse if they stop taking it. For example, relapse rates of bipolar disorder after stopping a mood stabilizer (such as aripiprazole) are 80% or higher.
“Active psychiatric illness is associated with poor outcomes for pregnancy, infants and mothers - and is considered an exposure for the child in the same way that taking a medication during pregnancy is an exposure,” Dr. Payne explained.
“The main reason to discontinue aripiprazole for pregnancy . . . would be if it is not working and the mother is actively ill, or if she insisted on doing so. In my mind, the literature supports the use of aripiprazole during pregnancy in mothers with serious mental illness who are responding well to the medication.”
One of the three study authors has ties to several pharmaceutical companies; the other two, including Dr. Cuomo, declared no conflicts of interest.
J Affect Disord 2107.