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First-trimester exposure to methylphenidate: a population-based cohort study.

Anton Pottegård1, Jesper Hallas, Jon T Andersen

  • 1Department of Clinical Pharmacology, University of Southern Denmark, JB Winsløwsvej 19, 2, 5000 Odense C, Denmark apottegaard@health.sdu.dk.

The Journal of Clinical Psychiatry
|February 8, 2014
PubMed
Summary
This summary is machine-generated.

First-trimester exposure to methylphenidate (a medication for ADHD) did not significantly increase the risk of major birth defects in a large Danish study. This finding is reassuring for pregnant women using this medication.

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Area of Science:

  • Obstetrics and Gynecology
  • Pharmacology
  • Developmental Toxicology

Background:

  • Methylphenidate use for Attention-Deficit/Hyperactivity Disorder (ADHD) is increasing among women of childbearing age.
  • Limited data exists on the safety of in utero methylphenidate exposure during pregnancy.

Purpose of the Study:

  • To evaluate the risk of major congenital malformations following first-trimester exposure to methylphenidate.
  • To provide evidence-based information for clinicians and patients regarding ADHD medication use during pregnancy.

Main Methods:

  • Utilized data from Danish national registries (2005-2012).
  • Propensity score matching compared 222 methylphenidate-exposed pregnancies to 2,220 unexposed pregnancies.
  • Controlled for maternal age, BMI, smoking, education, and concurrent medication use.

Main Results:

  • No statistically significant increase in overall major malformations (PPR=0.8; 95% CI, 0.3-1.8).
  • No significant increase in cardiac malformations (PPR=0.9; 95% CI, 0.2-3.0).
  • Sensitivity analyses confirmed these findings.

Conclusions:

  • First-trimester methylphenidate exposure is not associated with a substantially increased risk of major congenital malformations.
  • Results suggest a favorable safety profile for methylphenidate use in early pregnancy.