Safety of Concerta (Methylphenidate) During Pregnancy
Methylphenidate (Concerta) does not appear to be associated with major congenital malformations or other significant adverse obstetrical or developmental outcomes in pregnant women, though it carries a small increased risk for cardiac malformations and preeclampsia. 1
Safety Profile and Risks
Methylphenidate crosses the placental barrier and is classified as FDA Pregnancy Category C, meaning that animal studies have shown adverse effects on the fetus, but there are no adequate well-controlled studies in humans 2
The FDA maintains a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate, during pregnancy 2
Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes 2
There is a possible small increased risk for cardiac malformations (OR 1.59; 95% CI 1.02-2.49) with an absolute risk of approximately 1.7%, though some studies have not found this association 1, 3
A possible increased risk for gastroschisis (aOR 3.0; 95% CI 1.2-7.4) exists, though this represents a small absolute risk given the rarity of gastroschisis (population prevalence of 0.05%) 1
Obstetrical Outcomes
There is a possible increased risk for preeclampsia (aRR 1.29; 95% CI 1.11-1.49) associated with methylphenidate use, though this risk appears to be small 1, 4
Continued stimulant use in the second half of pregnancy may be associated with a small increased risk of preterm birth (aRR 1.30; 95% CI 1.10-1.55) 1, 4
A possible increased risk for spontaneous abortion exists, but confounding by indication cannot be ruled out 1
There may be a slightly increased risk for poor neonatal adaptation (23.6% vs 13.5%; P = .05) and NICU admission (aOR 1.5; 95% CI 1.3-1.7) 1
Clinical Considerations
CNS stimulants like methylphenidate can cause vasoconstriction and potentially decrease placental perfusion 2
The estimated background risk of major birth defects in the general U.S. population is 2% to 4%, and miscarriage is 15% to 20% in clinically recognized pregnancies 2
Animal studies showed no evidence of morphological development effects in rats at doses up to 12 times the maximum recommended human dose, though increased incidences of fetal skeletal variations were seen at the highest dose level 2
When methylphenidate was administered to rats throughout pregnancy and lactation, offspring body weight gain was decreased at doses 7 times the maximum recommended human dose 2
Recommendations for Management
For women with ADHD requiring treatment during pregnancy, the benefits of methylphenidate treatment should be weighed against the potential small increased risks 1, 2
Non-pharmacological interventions for ADHD should be considered during pregnancy when appropriate 5
If methylphenidate treatment is continued during pregnancy, monitor for signs of preeclampsia, especially in the latter half of pregnancy 1, 4
Consider fetal echocardiography for pregnant women using methylphenidate during pregnancy due to the small increased risk of cardiac malformations 3
Monitor infants for irritability, insomnia, and feeding difficulties if the mother was taking stimulants during pregnancy 5
The absolute increases in risks are small, and women with significant ADHD should not necessarily suspend their treatment based on these findings 4