What increased risk of congenital heart malformations has been associated with methylphenidate hydrochloride exposure during the first trimester of pregnancy?

First-trimester methylphenidate hydrochloride exposure was associated with 3 additional infants with congenital heart malformations per 1,000 exposed pregnancies versus unexposed pregnancies (pooled adjusted relative risk 1.3; 95% CI 1.0–1.6), without a suggested increase in overall birth defects.