Use in Pregnancy (Category B3): There are no adequate and well-controlled studies in pregnant women. Methylphenidate should not be prescribed for pregnant women unless, in the opinion of the physician, the potential benefits outweigh the possible risks.
As a general rule no drugs should be taken during the first 3 months of pregnancy, and the benefits and risks of taking drugs should be carefully considered throughout the whole of the pregnancy.
Adequate animal reproduction studies to establish safe use of methylphenidate during pregnancy have not been conducted. Oral administration of methylphenidate to rabbits during the period of organogenesis has produced teratogenic effects at systemic exposures (plasma AUC) approximately 3 times clinical exposure at the maximum recommended human dose. The exposure at the no-effect dose was less than human exposure. In rats, teratogenic effects were not seen at systemic exposures (plasma AUC) approximately 12 times clinical exposure at the maximum recommended human dose.
Use in Lactation: Case reports showed that methylphenidate was distributed into breast milk reaching a milk-to-plasma ratio of approximately 2.5. For safety reasons, mothers taking methylphenidate should refrain from breast-feeding their infants. A decision should be made by the prescriber whether the mother must abstain from breast-feeding or abstain from methylphenidate therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the mother.