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    Does ADHD medication use during pregnancy increase risk of congenital malformations?

    A new study published in JAMA Psychiatry has found that methylphenidate, a medication used to treat attention deficit hyperactivity disorder (ADHD), slightly increases the risk of heart defects during early pregnancy. The study, conducted at Brigham and Women’s Hospital, was the first to use data from the International Pregnancy Safety Study (InPreSS) consortium, which works to provide data on the safety of prescription medications during pregnancy.   

    The primary analyses for this study came from the 2000-2013 nationwide Medicaid Analytic eXtract, which looks at pregnant women aged 12 to 55 who were enrolled in Medicaid from the time of their last menstrual period (LMP) to 1 month after delivery. The researchers also used information from the Nordic health registries as validation analyses. The five Nordic countries included were Sweden, Norway, Iceland, Denmark, and Finland and the data were on all pregnancies resulting in singleton live births. However, each participating country contributed data from different periods according to data availability (Denmark, 2005-2012; Finland, 1996-2010; Iceland, 2003-2012; Norway, 2005-2012; and Sweden, 2006-2013). A total of 1 813 894 women were considered for the study and among them, 2072 (0.11%) had filled a prescription for an ADHD medication during their first trimester. 

    For the study, a pregnancy was considered exposed if a woman filled a prescription for a stimulant during the first 90 days of pregnancy. There were two different exposure groups that were examined: methylphenidate or amphetamine and dextroamphetamine. The researchers then looked at inpatient and outpatient International Classification of Diseases, Ninth Revision diagnoses and procedure codes in the maternal and infant health records to identify congenital malformations. An infant was considered to have a major congenital malformation if any of 13 specific malformation groups (central nervous system, ear, eye, cardiovascular, other vascular, respiratory, oral cleft, gastrointestinal, genital, urinary, musculoskeletal, limb, and other) were present.

    Malformations were diagnosed in 62966 infants who were not exposed to a stimulant during the first trimester (35.0 malformations per 1000 infants). The prevalence was higher among methylphenidate-exposed (n = 95; 45.9 per 1000) and among amphetamine-exposed n = 253; 45.4 per 1000) infants. The incidence of cardiovascular malformations was increased among methylphenidate-exposed infants (18.8 vs 12.7 per 1000 unexposed infants) and among amphetamine-exposed infants (15.4 per 1000). After the researchers adjusted for psychiatric morbidity, the associations with malformations overall were reduced for both methylphenidate (relative risk [RR], 1.16, 95% CI, 0.95-1.41) and amphetamines (RR, 1.18, 95% CI, 1.04-1.33). In terms of cardiovascular malformations, the risk remained slightly elevated for methylphenidate (RR, 1.27, 95% CI, 0.93-1.73) but not for amphetamines (RR, 1.07; 95% CI, 0.86-1.32). In fully adjusted analyses, the associations with malformations overall and with cardiovascular malformations were null for amphetamines. For any malformations, relative risk was 1.05 (95% CI, 0.93-1.19) and 0.96 (95% CI, 0.78-1.19) for cardiac malformations. The fully adjusted RRs for methylphenidate were 1.11 (95% CI, 0.91-1.35) for any malformation and 1.28 (95% CI, 0.94-1.74) for cardiac malformations.

    In the validation analyses, the Nordic cohort included 2,560,069 pregnancies resulting in a singleton live birth. Among these pregnancies, 1402 infants (0.05%) were exposed to methylphenidate. The prevalence of malformations was slightly lower than in the US cohort: 28.5 per 1000 infants for any malformation and 17.1 per 1000 infants for cardiovascular malformations. In unexposed pregnancies, the prevalence was 37.8 per 1000 infants for any malformation and 13.3 per 1000 infants for cardiovascular malformations. The adjusted estimates for first-trimester methylphenidate exposure from the US and the Nordic data resulted in RRs of 1.07 (95% CI, 0.91-1.26) for any malformation and 1.28 (95% CI, 1.00-1.64) for cardiovascular malformations. The researchers found a 28% increased prevalence of cardiac malformations after first-trimester exposure to methylphenidate.

    The authors noted that the major strength of the study was the collected data from 6 countries which helped provide a large pool of data and limited the risk of recall bias. However, since the data used did not track adherence to the prescription, it is possible that some of the pregnancies may have been misclassified. Another limitation noted is that both cohorts were restricted to live births, which could have resulted in underestimation of relative risk due to selection bias. Ultimately, the researchers noted that, when possible, women with mild to moderate ADHD symptoms should try to forego ADHD treatment during pregnancy. If daily function is difficult for the patient, however, she should be informed of the potential risk for cardiac malformation with methylphenidate.

    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.
    Ben Schwartz
    Ben Schwartz is Associate Editor, Contemporary OB/GYN.

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