From the Guidelines
Methylphenidate (Ritalin) can be used during pregnancy, but its use should be carefully considered and monitored due to potential small risks of cardiac malformations, gastroschisis, preeclampsia, preterm birth, and poor neonatal adaptation, as reported in a 2024 study published in the American Journal of Obstetrics and Gynecology 1.
Key Considerations
- The study found that methylphenidate does not seem to be associated with major congenital malformations or other significant adverse obstetrical or developmental outcomes 1.
- However, possible increased risks for cardiac malformations, gastroschisis, preeclampsia, preterm birth, and poor neonatal adaptation were noted, although these risks appear to be small and not consistently found across all studies 1.
- The decision to use methylphenidate during pregnancy should be individualized, taking into account the potential benefits and risks, as well as the severity of ADHD symptoms and their impact on daily functioning and prenatal care adherence.
Management Recommendations
- Healthcare providers should carefully weigh the potential benefits and risks of methylphenidate use during pregnancy and discuss these with their patients 1.
- Patients taking methylphenidate who become pregnant or are planning pregnancy should consult their healthcare provider immediately to discuss their specific situation and potential alternative treatments 1.
- Non-medication approaches, such as behavioral therapy, counseling, and lifestyle modifications, may be considered for managing ADHD symptoms during pregnancy 1.
From the FDA Drug Label
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. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations) No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 12 and 19 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adults on a mg/m2 basis However, spina bifida was observed in rabbits at a dose 65 times the MRHD given to adults. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 7 times the MRHD given to adults
Methylphenidate use during pregnancy is not entirely risk-free. While some studies have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, potential risks to the fetus associated with CNS stimulant use during pregnancy cannot be ruled out.
- Key findings include:
- No effects on morphological development in rats and rabbits at doses up to 12 and 19 times the MRHD
- Spina bifida observed in rabbits at a dose 65 times the MRHD
- Decrease in pup body weight in rats at doses 7 times the MRHD Given the uncertain risk, a conservative clinical decision would be to exercise caution when considering methylphenidate use during pregnancy, and to weigh the potential benefits against the potential risks 2.
From the Research
Methylphenidate Safety During Pregnancy
- The safety of methylphenidate (Ritalin) during pregnancy has been studied in several research papers 3, 4, 5, 6.
- A scoping review and meta-analysis of observational cohort studies found that methylphenidate exposure in early pregnancy is associated with a small but significant increased risk for major malformations, which can be attributed mostly to increased risk of cardiac malformations 3.
- Another study found that the data on stimulants (methylphenidate and amphetamines) are generally showing that there is no increase in the rate of major congenital anomalies 4.
- A systematic review and meta-analysis found that the maintenance of methylphenidate during pregnancy is safe, given that congenital anomalies and miscarriages did not appear to significantly increase 5.
- A review of evidence on methylphenidate use in pregnancy and lactation found that the number and size of the studies were small, and identified cases were not representative of the general adult ADHD population having methylphenidate as monotherapy during pregnancy 6.
Key Findings
- Methylphenidate exposure in early pregnancy may be associated with a small but significant increased risk for major malformations 3.
- There is no increase in the rate of major congenital anomalies with stimulants (methylphenidate and amphetamines) 4.
- The maintenance of methylphenidate during pregnancy is safe, given that congenital anomalies and miscarriages did not appear to significantly increase 5.
- Further studies are required to confirm the safety of methylphenidate during pregnancy 3, 5, 6.