A Prospective Cohort Study of Antipsychotic Medications in Pregnancy: The First 147 Pregnancies and 100 One Year Old Babies

Abstract

BackgroundMany women diagnosed with varying psychiatric disorders take antipsychotic medications during pregnancy. The safety of antipsychotic medications in pregnancy is largely unknown.MethodsWe established the National Register of Antipsychotic Medications in Pregnancy in 2005. Women who are pregnant and taking an antipsychotic medication are interviewed every 6 weeks during pregnancy and then followed until their babies are one year old. The baby's progress is closely followed for the first year of life.FindingsAs of April 18 2012, 147 pregnancies had been followed through to completion. There were 142 live births and data is available for 100 one year old babies. 18% of babies were born preterm, with a higher dose of antipsychotic medication correlating to an increased likelihood of premature delivery; 43% of babies required special care nursery or intensive care after birth; 37% had any degree of respiratory distress and 15% of babies developed withdrawal symptoms. Congenital anomalies were seen in eight babies. Most pregnancies resulted in the birth of live, healthy babies. The use of mood stabilisers or higher doses of antipsychotics during pregnancy increased the likelihood of babies experiencing respiratory distress or admission to Special Care Nursery or Neonatal Intensive Care Units.ConclusionThere is a great need for safety and efficacy information about the use of antipsychotic medications in pregnancy. Live, healthy babies are the most common outcome following the use of antipsychotic medication in pregnancy, but clinicians should be particularly mindful of neonatal problems such as respiratory distress.

Risks and benefits of psychotropic medication in pregnancy: cohort studies based on UK electronic primary care health records

“…Other research on antipsychotic treatment in pregnancy includes pharmacovigilance studies from drug companies' safety databases 76,77 as well as cohort studies based on various data sources. 38,50,[78][79][80][81][82][83][84][85] A systematic review 19 of many of these studies suggested that women requiring antipsychotic treatment during pregnancy have a higher risk of adverse birth outcomes. However, there was substantial heterogeneity between the studies and Coughlin et al 19 emphasise that most studies had limited adjustment for potential confounding and therefore the observed associations may not be causal.…”

Pharmacotherapy of obsessive-compulsive disorder during pregnancy: a clinical approach

“…When compared with healthy women, the risk was 1.5-2.5 times higher. [72][73][74]77 Overall, first generation antipsychotics (FGAs) and second generation antipsychotics (SGAs) have similar prevalence rates with regard to congenital malformations. 72,73 A prospective cohort study with a large sample size suggested that the increased risk of specific organ malformations was related solely to the cardiovascular system.…”

“…71,73 Several studies have reported a 1.7-2.5-fold increase in the risk of preterm birth (PTB) with use of antipsychotics. 72,74,77 Conversely, at least two prospective cohort studies suggest that use of SGAs was unrelated to the risk for PTB. 71,73 The literature has very conflicting results about birth weight.…”

“…71,73 The literature has very conflicting results about birth weight. A lack of difference between exposed and non-exposed women has been reported for mean birth weight 71,74,77 and proportion of small for gestational age infants. 74 Moreover, the risk of low birth weight 71,72,84 or proportion of small for gestational age infants was not reported to increase for exposed women.…”

“…74 Polytherapy, higher doses, and exposure in the last gestational week seem to be more related to these effects. 73,74,77 The prevalence of perinatal events has been reported as .8% for olanzapine, 73,81,84 9.5-25.8% for quetiapine, 73,84 and 23.5% for aripiprazole. 73 Newport et al 84 found that neonatal complications mostly involved the cardiovascular and respiratory systems.…”