Tuesday, October 6, 2015

Study Finds SGAs Do Not Substantively Increase Risk of Major Birth Defects

The use of second-generation antipsychotics (SGAs) during the first trimester does not appear to substantively increase the risk of major birth malformations, according to a report published today in AJP in Advance.

Given that discontinuation of medication during pregnancy can lead to relapse or worsening of illness in patients with psychiatric disorders, the results challenge the clinical practice of abruptly stopping maintenance treatment for psychiatric disorders during pregnancy, the study authors said.

Lee Cohen, M.D., of Massachusetts General Hospital along with researchers from several other institutions tracked the progress of 214 infants who were exposed to SGAs during the first trimester and a comparison group of 89 infants whose mothers had a history of psychiatric illness but who did not take SGAs during pregnancy. The women receiving SGAs were enrolled in the National Pregnancy Registry for Atypical Antipsychotics.

Three major malformations were identified among exposed infants. One infant had a transposition of the great arteries after first-trimester exposure to aripiprazole, quetiapine, bupropion, and labetalol. Another infant had a ventricular septal defect with surgical repair and had been exposed to ziprasidone, sertraline, and lamotrigine. Lastly, an imperforate hymen was identified in an infant exposed to aripiprazole, bupropion, and trihexyphenidyl. One major malformation was identified in the comparison group. The risk of major malformations reported in the exposed group was approximately two and a half times higher than in the unexposed group (6.2% versus 2.6%), although this was not statistically significant.

“Based on the 214 cases of first-trimester exposure to second-generation antipsychotics, it is reasonable to conclude that these agents as a class are not major teratogens,” the study authors wrote.

They concluded, “In summary, our results suggest that the use of a second-generation antipsychotic during the first trimester does not substantively increase the risk of major malformations. … [F]or 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.”

AJP Editor Robert Freedman, M.D., added, “As a field, we have become aware that both psychiatric illness itself and the drugs used to treat it can adversely affect the outcome of pregnancy. Cohen and colleagues have performed a careful study of matched groups of pregnant women with mental illness—those treated with second-generation antipsychotics versus those treated with other medications. At this point, it is helpful to clinicians to know that no evidence for a particular adverse risk profile for second-generation antipsychotics has emerged.”

For related information, see the Psychiatric News article “Study Examines Association Between SSRIs, Birth Defect Risks.”

(Image: pio3/Shutterstock)


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