This article is more than 5 years old. Information may no longer be current.

First-trimester exposure to second-generation antipsychotics slightly increases risk for birth defects

Exposure to second-generation antipsychotics during the first trimester did not significantly increase risk for major malformations among infants, according to study findings in the American Journal of Psychiatry.

“In 2008, the National Pregnancy Registry for Atypical Antipsychotics was established in an ongoing effort to obtain reproductive safety data regarding fetal exposure to second-generation antipsychotics … The objective of this Registry is to obtain reproductive safety data, such as teratogenicity and risk for adverse obstetrical and neonatal outcomes associated with in utero exposure to second-generation antipsychotics,” Lee S. Cohen, MD, of Massachusetts General Hospital, Boston, and colleagues wrote.

Researchers prospectively followed women during pregnancy and the postpartum period and reviewed obstetric, labor, delivery and pediatric medical records to assess risk for major malformations among infants exposed to second-generation antipsychotics during pregnancy. Study participants were aged 18 to 45 years. The final study cohort included 214 women taking second-generation antipsychotics and 89 controls.

Three major malformations were confirmed among the 214 live births exposed to second-generation antipsychotics in the first trimester. One major malformation was confirmed in the control group.

The absolute risk for major malformations was 1.4% for exposed infants and 1.1% for unexposed infants.

Exposed infants had an odds ratio of 1.25 (95% CI, 0.13-12.19) for major malformations compared with unexposed infants.

“Our results suggest that the use of a second-generation antipsychotic during the first trimester does not substantively increase the risk of major malformations,” Cohen and colleagues wrote. “The present findings challenge the frequently observed clinical practice of abruptly stopping maintenance treatment for psychiatric disorders during pregnancy. A major clinical implication of these findings is that for women with substantial psychiatric morbidity and good response to a second-generation antipsychotic, maintenance treatment with a second-generation antipsychotic during pregnancy may be the most prudent treatment option, similar to recommendations for continued treatment for pregnant women with other serious and chronic medical conditions, such as epilepsy.” – by Amanda Oldt

Disclosure: Cohen reports receiving research support for the National Pregnancy Registry for Atypical Antipsychotics from AstraZeneca, Bristol-Myers Squibb/Otsuka, Ortho-McNeil-Janssen Pharmaceuticals, Pfizer, and Sunovion Pharmaceuticals; receiving other research support from Abbott Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Berlex Laboratories, Cephalon, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Janssen Pharmaceuticals, the National Alliance for Research on Schizophrenia and Depression, the National Institute on Aging, NIH, NIMH, Organon, Sanofi-Synthelabo, Sepracor, Stanley Medical Research Institute, Takeda/Lundbeck, van Ameringen Foundation, Wyeth-Ayerst Pharmaceuticals, and Wyeth Pharmaceuticals; receiving consulting fees from Eli Lilly, GlaxoSmithKline, Janssen Pharmaceuticals, JDS/ Noven Pharmaceuticals, Novartis Pharmaceuticals, Ortho-McNeil Pharmaceuticals, Pamlab, Sepracor, and Wyeth-Ayerst Pharmaceuticals; and receiving honoraria from AstraZeneca, Berlex Pharmaceuticals, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Janssen Pharmaceuticals, Pfizer, and Wyeth-Ayerst Pharmaceuticals. Please see the full study for a list of all authors’ relevant financial disclosures.