It’s a legitimate concern for women who are pregnant or who would like to become pregnant: Should I continue to take the medication that controls my mental illness, or could it harm my baby?

For the first time, researchers have sought to answer that question. Women increasingly are taking antipsychotic medications while pregnant to control illnesses such as bipolar disorder and schizophrenia, even though conclusive answers about whether these medications cause birth defects have been lacking.

In a massive study of 1.3 million pregnant women, researchers from Brigham and Women’s Hospital and Harvard Medical School concluded that, after accounting for co-existing mental and physical conditions and their associated behaviors, the risk of birth defects is not significant.1

There is one possible exception – risperidone (Risperdal), a medication that has come under fire for, among other things, causing boys to grow breasts.

“Whenever possible, given incomplete knowledge regarding the reproductive safety profiles of many pharmacologic agents, medications should be avoided during pregnancy,” the authors wrote. “However, frequently avoidance is not possible, as is the case for women with schizophrenia, bipolar disorder or major depressive, in which few alternative treatment options are available.”

Make no mistake – the odds of having a child with birth defects while taking antipsychotics is elevated, particularly among newer medications.

Make no mistake – the odds of having a child with birth defects while taking antipsychotics is elevated, particularly among newer medications. Here are some of the study’s findings:

Among women not taking antipsychotics, 32.7 per 1,000 births were diagnosed with congenital malformations. That’s compared to 44.5 per 1,000 births among those taking newer (atypical) antipsychotics. The most commonly taken newer medications were quetiapine (Seroquel), ariprazole (Abilify), Risperdal, olanzapine (Zyprexa) and ziprasidone (Geodon).

The number of birth defects per 1,000 were slightly lower for the older-line (typical) antipsychotics, at 38.2.

The women taking antipsychotics during the first trimester tended to be older than the mean age of 24, were more likely to be white, and were more likely to deliver prematurely, according to the study. “They had a much higher burden of co-occurring illness than untreated women as judged by the differences in baseline characteristics. They had more psychiatric and neurologic conditions and other co-occurring conditions, used more psychotropic medications and suspected teratogens (agents that caused malformed embryos), and were generally in poorer health.”

The Dangers of Going Off Medications While Pregnant

The authors conducted the study by analyzing data from a nationwide Medicaid database. They defined “antipsychotic use” as having filled at least one prescription during the first 90 days of pregnancy.

“Our findings suggest that use of APs (antipsychotics) early in pregnancy does not meaningfully increase the risk for congenital malformation or cardiac malformation, with the possible exception of risperidone,” the authors concluded. “The findings for risperidone should be viewed as an initial safety signal that will require confirmation in other studies.”

The study is timely in that more pregnant women are taking antipsychotics than ever before. “Exposure to antipsychotics (APs) during pregnancy is increasingly common,” the authors wrote. “Most newer atypical drugs are less likely to affect fertility than the older typical APs. This unimpaired fecundity combined with deinstitutionalization of patients with psychiatric illness and more widespread off-label use of these drugs have resulted in a doubling of the use of APs during pregnancy in the last decade.”

In an accompanying JAMA editorial, Dr. Katherine L. Wisner of the Northwestern University Feinberg School of Medicine, Chicago, called the research a “landmark report.”2

She pointed out that the conventional wisdom of “don’t take medications if you’re pregnant” in essence puts mothers with a multitude of illnesses in harm’s way. This is particularly true because there is rarely any research published that quantifies the risks of taking medications while pregnant, partly due to ethical considerations.

But it’s a difficult dilemma. “Medication use by pregnant women is increasing across time and now is nearly universal,” Wisner and co-authors wrote. “In 2008, nearly 94 percent of women took at least one medication during pregnancy. In the first trimester, 82.3 percent used at least one and 27.6 percent reported taking four or more medications. These staggering statistics highlight the public health importance of research to inform pharmacotherapy for pregnant women.”

In the case of discontinuing medication among seriously mentally ill pregnant women, the result can be harmful to the baby as well as the mother. Women may not eat properly under circumstances of mania or depression, they may place themselves in dangerous situations due to lapses in judgement, or they may have cardiovascular events resulting from anxiety, mania or other symptoms.

“Nowhere in medicine is the need for personalization of care so crucial than during pregnancy. Personalization of the treatment for serious mental illness with consideration of pregnancy and the mother’s capacity to provide sustenance for the growing fetus and newborn,” the editorial concluded.

In a 2013 report in Current Psychiatry, the authors concluded that “quetiapine (Seroquel) is a reasonable first choice when a new atypical antipsychotic is indicated for a pregnant patient.”3 They added that “treatment with atypical antipsychotics during pregnancy may increase the risk of adverse birth outcomes, but inadequately controlled mental illness also carries some degree of risk. The decision to use any atypical antipsychotic during pregnancy must be based on an individualized assessment of risks and benefits and made by the pregnant patient and her provider.”


1.Huybrechts, Krista et. al. Antipsychotic Use in Pregnancy and the Risk for Congenital Malformations. (17 Aug., 2016). JAMA Psychiatry. Retrieved Sept. 3, 2016, from
2.Wisner, Katherine L. (17 Aug. 2016). Use of Antipsychotics During Pregnancy. JAMA Psychiatry. Retrieved Sept. 3, 2016, from
3.Atypical Antipsychotics during Pregnancy. (12 July 2013). Current Psychiatry. Retrieved Sept. 3, 2016, from

Written by David Heitz