The Risks of Taking Ritalin During a Pregnancy

What are the Risks of Ritalin Use During Pregnancy?

Ritalin has been classified as a pregnancy category C drug by the U.S. Food and Drug Administration.¹ This means that although there have been no well-controlled studies conducted in pregnant women, studies using lab animals have shown that Ritalin exposure can have adverse effects on the fetus.²  

Although very high doses of Ritalin have been associated with certain malformations observed in rabbits and rats, most animal studies using a dose relevant to that taken by humans do not indicate an increased risk of birth defects.³

A large retrospective study found that infants born to mothers who took Ritalin during the first trimester of pregnancy have a small increased risk of developing certain heart defects.⁴ Based on the study findings, there will be an additional three infants born with congenital heart defects for every 1,000 women who take Ritalin during the first trimester. 

Other medical reports concerning children exposed to Ritalin during pregnancy describe two cases of babies born with finger abnormalities and one case of a baby born with limb malformations.⁵ Other noted problems associated with prenatal Ritalin exposure include premature birth, asphyxia, and growth retardation. 

Another large population-based study published determined that pregnant women who use Ritalin are at an increased risk of developing preeclampsia, a potentially dangerous pregnancy complication characterized by high blood pressure, swelling of hands and feet, and protein in urine.⁶ 

Is Ritalin Safe to Use During Breastfeeding?

Ritalin is able it to enter breast milk due to its small size and solubility. Studies have shown that the relative infant dose (the ratio of the amount of drug ingested by the baby compared with the maternal dose) of Ritalin is 0.7%.⁷ 

Because relative infant doses below 10% are considered safe in breastfeeding, these findings suggest little infant exposure to Ritalin via breast milk. A recent case report of an infant exposed to Ritalin during breastfeeding also described normal development with no detectable congenital abnormalities.⁵ 

Treatment Options

If you currently use Ritalin and are pregnant or planning to become pregnant, please have a discussion with your physician regarding medication options and alternative treatment strategies. Ritalin should only be used during pregnancy if the potential benefits outweigh the potential risks to both the fetus and mother.

Sources

1. Novartis Pharmaceuticals Corporation. (2010). Ritalin hydrochloride (methylphenidate hydrochloride).
2. U.S. Department of Health and Human Services. (2019). FDA Pregnancy Categories.
3. Beckman, D.A., Schneider, M., Youreneff, M., & Tse, F.L. (2008). Developmental toxicity assessment of D,L-methylphenidate and D-methylphenidate in rats and rabbits. Birth Defects Research. Part B, Developmental and Reproductive Toxicology, 83(5), 489-501.
4. Huybrechts, K., Bröms, G., Christensen, L.B., Einarsdóttir, K., Engeland, A., … & Bateman, B.T. (2018). Association Between Methylphenidate and Amphetamine Use in Pregnancy and Risk of Congenital Malformations: A Cohort Study From the International Pregnancy Safety Study Consortium. JAMA Psychiatry, 75(2), 167-175.
5. Bolea-Alamanac, B.M., Green, A., Verma, G., Maxwell, P., & Davies, S.J. (2014). Methylphenidate use in pregnancy and lactation: a systematic review of evidence. British Journal of Clinical Pharmacology, 77(1), 96-101.
6. Cohen, J.M., Hernández-Díaz, S., Bateman, B.T., Park, Y., Desai, R.J., Gray, K.J., … & Huybrechts, K.F. (2017). Placental Complications Associated With Psychostimulant Use in Pregnancy. Obstetrics & Gynecology, 130(6), 1192–1201.
7. Hackett, L.P., Ilett, K.F., Kristensen, J.H., Kohan, R., & Hale, T.W. (2005). Infant dose and safety of breastfeeding for dexamphetamine and methylphenidate in mothers with attention deficit hyperactivity disorder. Therapeutic Drug Monitoring, 27(2), 220–221.