Central Stimulant
PREGNANCY RECOMMENDATION: No Human Data—Animal Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Potential Toxicity
PREGNANCY SUMMARY
No reports describing the use of dexmethylphenidate in human pregnancy have been located. No teratogenicity was observed in two animal species, but the maximum maternal systemic exposures obtained were very close to those measured in humans clinically. Reported pregnancy exposures to methylphenidate, a closely related agent, are limited, but have not shown a major risk for embryo–fetal harm (see also Methylphenidate). Until human data are available for dexmethylphenidate, the safest course is to avoid the drug in pregnancy. If the mother’s condition requires the drug, the lowest effective dose, avoiding the 1st trimester if possible, should be used. Long-term follow-up of exposed offspring may be warranted.
FETAL RISK SUMMARY
Dexmethylphenidate is a CNS stimulant that is indicated for the treatment of attention deficit/hyperactivity disorder (ADHD). There are no active metabolites. The mean plasma elimination half-life is about 2.2 hours (1).
Reproduction studies have been conducted in rats and rabbits. No evidence of teratogenicity was observed in rats treated during organogenesis with doses resulting in maternal plasma levels (AUC) up to five times the levels (AUC) obtained in adult humans taking the recommended dose of 20 mg/day (RHD). However, at the highest dose, delayed skeletal ossification was seen. When doses resulting in plasma levels up to five times the RHD were given throughout gestation and lactation, the highest dose resulted in decreased postweaning body weight in male offspring. In rabbits, no evidence of teratogenicity was observed at plasma levels up to one time the RHD (1).
It is not known if dexmethylphenidate crosses the human placenta. The molecular weight (about 234 for the free base) suggests that the drug will cross to the embryo and/or the fetus. The relatively short half-life, however, should limit the amount crossing the placenta.
BREASTFEEDING SUMMARY
No reports describing the use dexmethylphenidate during human lactation have been located. The molecular weight (about 234 for the free base) is low enough that excretion into breast milk should be expected. However, the relatively short plasma elimination half-life should limit the amount of the drug in milk. The effect of this exposure on a nursing infant is unknown. If a mother chooses to breastfeed while taking dexmethylphenidate, the infant should be monitored for adverse effects observed in children and adults (e.g., abdominal pain, fever, anorexia, and nausea).
Reference
1.Product information. Focalin. Novartis Pharmaceuticals, 2003.