Pregnancy: Risk summary: There is insufficient experience with use of methylphenidate in pregnant women. Ritalin should not be given to pregnant women unless the potential benefit outweighs the risk to the fetus. Methylphenidate is potentially teratogenic in rabbits.
Animal data: Methylphenidate is considered to be possibly teratogenic in rabbits. Spina bifida with malrotated hind limbs was observed in two separate litters at a dose of 200 mg/kg/day. Exposure (AUC) at this dose was approximately 5.1 times higher than the extrapolated exposure at the MRHD. Exposure at the next lower dose, wherein no spina bifida was found, was 0.7 times the extrapolated exposure at MRHD. A second study was conducted with a high dose of 300 mg/kg, which was considered maternally toxic. No spina bifida was seen in 12 litters (92 fetuses) surviving. Exposure (AUC) at 300 mg/kg was 7.5 times the extrapolated exposure at MRHD.
Methylphenidate is not teratogenic in rats. Development of fetal toxicity was noted at a high dose of 75 mg/kg (20.9 times higher than the exposure (AUC) at MRHD) and consisted of an increase of the instance of fetuses with delayed ossification of the skull and hyoid bones as well as fetuses with short supernumerary ribs.
When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day (about 26-fold higher than the MRHD on a mg/kg basis), offspring body weight gain was decreased at the highest dose, but no other effects on postnatal development were observed.
Lactation: Risk summary: 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).
A decision should be made whether to abstain from breast-feeding or to abstain from Ritalin therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman.
Females and males of reproductive potential: There are no data to support special recommendation in women of child-bearing potential.
Infertility: No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice (see Pharmacology: Toxicology: NON-CLINICAL SAFETY DATA under Actions).