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 made on a case-by-case basis, weighing the potential benefits against the potential risks, and considering alternative treatments such as behavioral therapy and counseling.
Recommendations
- If methylphenidate is deemed necessary during pregnancy, the lowest effective dose should be used, and the patient should be closely monitored throughout pregnancy 1.
- Patients should be informed of the potential risks and benefits of methylphenidate use during pregnancy and involved in the decision-making process.
- Non-medication approaches should be considered as first-line options during pregnancy, and medication use should be reserved for cases where the potential benefits clearly outweigh the risks.
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.
Methylphenidate may not be completely safe to use during pregnancy. Although 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 the use of CNS stimulants during pregnancy cannot be ruled out. Key considerations include:
- Embryo-fetal development studies in rats and rabbits showed no morphological development effects at doses up to 12 and 19 times the MRHD, respectively.
- Spina bifida was observed in rabbits at a dose 65 times the MRHD.
- Decreased offspring body weight gain was observed in rats at doses 7 times the MRHD. It is essential to weigh the potential benefits and risks of using methylphenidate during pregnancy and to monitor patients closely. 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.