This is the second part of a two part series on the use of antipsychotic medications during pregnancy. Read Part 1 here, which reviews data from the Australian antipsychotic registry.
Atypical antipsychotic medications are commonly used for the treatment of schizophrenia and bipolar disorder. Despite the increasing use of these medications in women of child-bearing age, there is still relatively little data regarding the reproductive safety and long-term neurodevelopmental effects of these medications. Last week we presented preliminary data from the Australian National Register of Antipsychotic Medication in Pregnancy (NRAMP).
Complementing this data is a report presented at the annual meeting of the American Society of Clinical Psychopharmacology. Researchers from the CWMH, including Drs. Lee Cohen and Adele Viguera, presented preliminary data from The National Pregnancy Registry for Atypical Antipsychotics.
In this prospective study, pregnant women between the ages of 18 and 45 years were recruited. Women were eligible for inclusion if they had used an atypical antipsychotic at any point during pregnancy; a comparison group was comprised of women who have not been exposed to these agents. Three phone interviews were conducted: 1) at baseline, proximate to the time of enrollment, 2) at 7 months of gestation, and 3) at 2-3 months postpartum. Obstetrical and pediatric medical records were used to supplement maternal reporting.
A trained research assistant abstracted relevant information regarding primary and secondary outcomes including: 1) rates of major malformations in infants, 2) birth weight, 3) gestational age at delivery, 4) miscarriage rates, and 5) delivery complications. Data on maternal health outcomes during pregnancy, including weight gain across pregnancy and evidence of gestational hypertension/diabetes, were also obtained. Potential major malformations were identified and confirmed by a dysmorphologist blinded to drug exposure.
As of April 2014, a total of 408 women had enrolled in the registry: 300 women in the exposed group and 108 women in the comparison group. The overall dropout rate was 12.5% and was similar in the two groups. Of the women who reached the postpartum interview, medical records were obtained from 90% of the participants.
Rates of major malformations in the two groups were similar: 1.5% (3/200 live births) in the group exposed to atypical antipsychotics and 1.2% (1/84) in the comparison group. The risk ratio for major malformations was 1.26 (0.13, 11.85) comparing exposed to unexposed infants, a difference which did not have statistical significance.
The following malformations were detected:
- Transposition of the great arteries (Aripiprazole/Quetiapine)
- Imperforate hymen (Aripiprazole)
- Ventricular septal defect (VSD) with surgical repair (Ziprasidone)
The rates of malformation reported in this study were considerably lower than those reported in the Australian study (5.6%). This may reflect differences in the methodologies used or in the patient populations studied. Or it may just be the type of statistical variation seen when small samples are studied and compared.
While this preliminary data is reassuring, larger numbers of participants are needed to provide more complete reproductive safety data regarding atypical antipsychotics as a class and for the individual drugs in this category of medications.
The National Pregnancy Registry for Atypical Antipsychotics is dedicated to evaluating the safety of atypical antipsychotic medications that may be taken by women during pregnancy. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is inconclusive. CALL TOLL-FREE to learn more: 1-866-961-2388 or email at firstname.lastname@example.org.
The registry is continuing to recruit pregnant women aged 18-45 years who are treated with one or more atypical antipsychotics, and will prospectively follow them for a spectrum of outcomes, including organ malformations and maternal or newborn complications. These drugs include aripiprazole (Abilify), clozapine (Clozaril), ziprasidone (Geodon), paliperidone (Invega), risperidone (Risperdal), quetiapine (Seroquel), olanzapine (Zyprexa), asenapine (Saphris), lurasidone (Latuda), and Iloperidone (Fanapt).
Ruta Nonacs, MD PhD
Cohen LS, Viguera AC, McInerney K, et al. The National Pregnancy Registry for Atypical Antipsychotics: Effects of Fetal Exposure on Risk for Major Malformations. Presented at the Annual Meeting of the American Society of Clinical Psychopharmacology, June 2014.