March 19th 2014 | Ruta Nonacs, MD PhD
Methylphenidate, the active ingredient in Ritalin and Concerta, is commonly used to treat ADHD. We now have several reports assessing its reproductive safety.
The most recent study comes from Denmark, where there was no statistically significant difference between the two groups (methylphenidate-exposed and unexposed) in terms of risk for major malformations or cardiac malformations.
In another report, four of 180 (2.2%) children exposed to methylphenidate had major malformations, which is similar to the rate of 2-4% observed in the general population; thus it appears that exposure during pregnancy does not appear to be associated with a substantially increased risk of congenital malformations.
While these two reports are reassuring with regard to the risk of malformations, they did not include information on other outcomes, such as gestational age or birth weight. In a small study, methylphenidate use during pregnancy was associated with increased risk of premature birth, growth retardation and neonatal withdrawal symptoms (Debooy 1993). Unfortunately, this study included only 38 participants and was further confounded by the fact that these women were abusing methylphenidate and may have also used nicotine, alcohol and other drugs during their pregnancy.
Based on the two studies we have, the available data for methylphenidate suggest no increase in the risk of malformation when used at therapeutic doses; however, these infants may be at increased risk for low birth weight or preterm birth.It is likely that these adverse outcomes are more of a risk in women taking very high, as opposed to therapeutic, doses of stimulant, but further study is required to determine the risk of these outcomes in women taking therapeutic doses of stimulants.
- Debooy VD, Seshia MM, Tenenbein M, Casiro OG. Intravenous pentazocine and methylphenidate abuse during pregnancy. Maternal lifestyle and infant outcome.<http://www.ncbi.nlm.nih.gov/pubmed/7692723> Am J Dis Child. 1993 Oct;147(10):1062-5.
- Dideriksen D, Pottegård A, Hallas J, Aagaard L, Damkier P. First trimester in utero exposure to methylphenidate.<http://www.ncbi.nlm.nih.gov/pubmed/23136875> Basic Clin Pharmacol Toxicol. 2013 Feb;112(2):73-6.
- Pottegård A, Hallas J, Andersen JT, et al. First-trimester exposure to methylphenidate: a population-based cohort study.<http://www.ncbi.nlm.nih.gov/pubmed/24502866> J Clin Psychiatry. 2014 Jan;75(1):e88-93.