First-Trimester Exposure to Methylphenidate: A Population-Based Cohort Study

TY - JOUR

T1 - First-Trimester Exposure to Methylphenidate

T2 - A Population-Based Cohort Study

AU - Pottegård, Anton

AU - Hallas, Jesper

AU - Andersen, Jon T

AU - Løkkegaard, Ellen C L

AU - Dideriksen, Dorthe

AU - Aagaard, Lise

AU - Damkier, Per

N1 - © Copyright 2014 Physicians Postgraduate Press, Inc.

PY - 2014/1

Y1 - 2014/1

N2 - OBJECTIVE: The use of methylphenidate to treat attention-deficit/hyperactivity disorder has risen dramatically in Western countries, and it is increasingly used by adults, including women of childbearing age. Very little is known about potential hazards of in utero exposure to methylphenidate. We conducted this study to estimate the risk of major congenital malformations following first-trimester in utero exposure to methylphenidate.METHOD: Data from 2005 to 2012 were extracted from the Danish National Patient Register, the Danish National Prescription Registry, the Medical Birth Registry, and the Danish Civil Registration System. Exposure was defined as having redeemed 1 or more prescriptions for methylphenidate within a time window defined as 14 days before the beginning of the first trimester up to the end of the first trimester. Each exposed subject was propensity score-matched to 10 unexposed subjects with respect to maternal age, smoking status, body mass index, length of education, calendar year of completion of pregnancy, and concomitant use of antipsychotics, antidepressants, anxiolytics, and nonsteroidal anti-inflammatory drugs.RESULTS: We included 222 exposed and 2,220 unexposed pregnancies in the analysis. There was no statistically significant increase in major malformations (point prevalence ratio = 0.8; 95% CI, 0.3-1.8) or cardiac malformations (point prevalence ratio = 0.9; 95% CI, 0.2-3.0). Sensitivity analyses using different definitions of exposure or previous users of methylphenidate as the unexposed comparison cohort yielded comparable results.CONCLUSIONS: First-trimester in utero exposure to methylphenidate does not appear to be associated with a substantially (ie, more than 2-fold) increased overall risk of major congenital malformations.

AB - OBJECTIVE: The use of methylphenidate to treat attention-deficit/hyperactivity disorder has risen dramatically in Western countries, and it is increasingly used by adults, including women of childbearing age. Very little is known about potential hazards of in utero exposure to methylphenidate. We conducted this study to estimate the risk of major congenital malformations following first-trimester in utero exposure to methylphenidate.METHOD: Data from 2005 to 2012 were extracted from the Danish National Patient Register, the Danish National Prescription Registry, the Medical Birth Registry, and the Danish Civil Registration System. Exposure was defined as having redeemed 1 or more prescriptions for methylphenidate within a time window defined as 14 days before the beginning of the first trimester up to the end of the first trimester. Each exposed subject was propensity score-matched to 10 unexposed subjects with respect to maternal age, smoking status, body mass index, length of education, calendar year of completion of pregnancy, and concomitant use of antipsychotics, antidepressants, anxiolytics, and nonsteroidal anti-inflammatory drugs.RESULTS: We included 222 exposed and 2,220 unexposed pregnancies in the analysis. There was no statistically significant increase in major malformations (point prevalence ratio = 0.8; 95% CI, 0.3-1.8) or cardiac malformations (point prevalence ratio = 0.9; 95% CI, 0.2-3.0). Sensitivity analyses using different definitions of exposure or previous users of methylphenidate as the unexposed comparison cohort yielded comparable results.CONCLUSIONS: First-trimester in utero exposure to methylphenidate does not appear to be associated with a substantially (ie, more than 2-fold) increased overall risk of major congenital malformations.

KW - Abnormalities, Drug-Induced

KW - Adult

KW - Central Nervous System Stimulants

KW - Cohort Studies

KW - Denmark

KW - Female

KW - Humans

KW - Methylphenidate

KW - Pregnancy

KW - Pregnancy Trimester, First

KW - Registries

KW - Risk

KW - Young Adult

U2 - 10.4088/JCP.13m08708

DO - 10.4088/JCP.13m08708

M3 - Journal article

C2 - 24502866

SN - 0160-6689

VL - 75

SP - e88-93

JO - Journal of Clinical Psychiatry

JF - Journal of Clinical Psychiatry

IS - 1

ER -