Medikinet Use In Pregnancy & Lactation

Pregnancy: Data from a cohort study of in total approximately 3,400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects. There was a small increased occurrence of cardiac malformations (pooled adjusted relative risk, 1.3; 95% CI, 1.0-1.6) corresponding to 3 additional infants born with congenital cardiac malformations for every 1000 women who receive methylphenidate during the first trimester of pregnancy, compared with non-exposed pregnancies.
Cases of neonatal cardio-respiratory toxicity, specifically foetal tachycardia and respiratory distress have been reported in spontaneous case reports.
Studies in animals have only shown evidence of reproductive toxicity at maternally toxic doses (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Methylphenidate is not recommended for use during pregnancy unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy.
Lactation: Case reports showed that methylphenidate was distributed into breast milk reaching a milk-to-plasma ratio of approximately 2.5 (see Pharmacology: Pharmacokinetics under Actions). For safety reasons, mothers taking methylphenidate should refrain from breast-feeding their infants.