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    Do antipsychotics increase risk of congenital malformations?


    Analysis of a nationwide sample of pregnant women provides reassurance about use of antipsychotic medication in the first trimester while raising concern about a potential link between one particular drug in this class and congenital malformations. The findings, published in JAMA Psychiatry, represent outcomes from more than 1.3 million pregnancies.

    The data reviewed were from 1,341,715 women who were represented in the Medicaid Analytic Extract database from January 1, 2000 to December 31, 2010. The participants had been enrolled in Medicaid from 3 months before their last menstrual period until at least 1 month after delivery of a live-born infant. To estimate the relative risk of congenital malformations associated with use of antipsychotic medication, the authors used generalized linear models with fine stratification on the propensity score to control for underlying psychiatric disorders and other confounders.

    During the first trimester, 9258 (0.69%) of the women filled at least 1 prescription for an atypical antipsychotic medication and 733 (0.05%) filled at least 1 prescription for a typical antipsychotic medication. Congenital malformations were reported in 32.7 per 1000 births that were not exposed to the drugs versus 44.5 per 1000 births exposed to atypical antipsychotic medications and 38.2 per 1000 births exposed to typical antipsychotic medications.

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    Risk of malformations was increased by exposure to the atypical drugs (relative risk [RR], 1.36; 95% CI, 1.24-1.50) but not by exposure to the typical antipsychotic agents. After adjustment for confounding, the RR fell to 1.05 (95% CI, 0.96-1.16) for the atypical agents and 0.90 (95% CI, 0.62-1.31) for the typical antipsychotic drugs. Similar findings were reported for cardiac malformations.

    Looking at individual antipsychotic agents, the authors found that risperidone was associated with a small increased risk of overall malformations (RR, 1.26; 95% CI, 1.02-1.56) and of cardiac malformations (RR, 1.26; 95% CI, 0.88-1.81), which was not statistically significant. Both were independent of the confounders measured.

    The researchers concluded that use of antipsychotic drugs in the first trimester “does not meaningfully increase the risk of congenital malformations overall or cardiac malformations in particular.” They also said that additional study was required of the association seen between risperidone and increased risk of malformations.  

    NEXT: Is the current standard for prenatal carrier screening too limited?

    Judith M. Orvos, ELS
    Judith M. Orvos, ELS, is a a BELS-certified medical writer and editor and an editorial consultant for Contemporary OB/GYN.
    Miranda Hester
    Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.


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