Methylphenidate (Ritalin) Use During Pregnancy
Methylphenidate (Ritalin) during pregnancy does not appear to be associated with major congenital malformations or significant adverse developmental outcomes, but it carries a small increased risk for cardiac malformations and preeclampsia that should be considered in treatment decisions. 1, 2
Safety Profile
- Methylphenidate crosses the placenta but has not been associated with major birth defects or adverse maternal/fetal outcomes according to FDA labeling 2
- The FDA maintains a pregnancy exposure registry for women taking ADHD medications during pregnancy (National Pregnancy Registry for Psychostimulants at 1-866-961-2388) 2
- Overall, methylphenidate does not seem to be associated with major congenital malformations or other significant adverse obstetrical or developmental outcomes 1
Potential Risks
- 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) has been reported, though this represents a small absolute risk given the rarity of gastroschisis (population prevalence of 0.05%) 1
- Preeclampsia risk may be slightly elevated (aRR, 1.29; 95% CI, 1.11-1.49) 1, 4
- Possible increased risk for preterm birth (aOR, 1.3; 95% CI, 1.1-1.6) 1, 4
- Some studies suggest a possible increased risk for spontaneous abortion, though confounding by indication cannot be ruled out 1
Clinical Considerations
- Animal studies showed no effects on morphological development at doses up to 12 times the maximum recommended human dose in rats and 19 times in rabbits 2
- The estimated background risk of major birth defects in the general U.S. population is 2-4%, and miscarriage is 15-20% 2
- CNS stimulants like methylphenidate can cause vasoconstriction and potentially decrease placental perfusion 2
- Monitor infants for poor neonatal adaptation, which has been reported at slightly higher rates (23.6% vs 13.5%) 1
- Infants should be monitored for irritability, insomnia, and feeding difficulties if the mother was taking methylphenidate during pregnancy 2
Breastfeeding Considerations
- Methylphenidate is present in human milk, resulting in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage 2
- The milk/plasma ratio ranges between 1.1 and 2.7 2
- No reports of adverse effects on breastfed infants have been documented 2
- Monitor breastfeeding infants for potential adverse reactions such as agitation, insomnia, anorexia, and reduced weight gain 2
Treatment Algorithm
For women planning pregnancy or who become pregnant while taking methylphenidate:
If continuing methylphenidate during pregnancy:
For postpartum care:
Common Pitfalls and Caveats
- Avoid assuming that all ADHD medications carry the same risk profile during pregnancy; risks may differ between stimulants and non-stimulants 1
- Remember that untreated severe ADHD may pose risks to both mother and fetus through impaired self-care, adherence to prenatal care, and increased risk-taking behaviors 1
- The FDA pregnancy category system referenced in older literature has been replaced with more descriptive pregnancy risk information 6
- Information provided regarding methylphenidate use during pregnancy applies to therapeutic use and does not apply to non-prescribed use 2