Dexmethylphenidate / serdexmethylphenidate Pregnancy and Breastfeeding Warnings

Brand names: Azstarys

Medically reviewed by Drugs.com. Last updated on Aug 22, 2023.

Dexmethylphenidate / serdexmethylphenidate Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no data available on use of this drug in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes; published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, although there may be risks to the fetus associated with the use of CNS stimulants during pregnancy.

Comments:
-There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to medications used for ADHD (attention deficit hyperactivity disorder); healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

Animal studies have shown delayed fetal skeletal ossification at dexmethylphenidate doses up to 3 times the maximum recommended human dose (MRHD) in rats. At this same dose, decreased weight was observed in male pups in pre- and post-natal development studies. In an embryo-fetal development study with serdexmethylphenidate in rabbits, developmental effects were not observed at doses up to approximately 49 times the MRHD. There is concern that CNS stimulants may cause vasoconstriction and decrease placental perfusion. Fetal and/or neonatal adverse reactions have not been reported with therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Dexmethylphenidate / serdexmethylphenidate Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown (serdexmethylphenidate/dexmethylphenidate) Yes (methylphenidate)

Comments:
-Breastfed infants should be monitored for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
-Long term neurodevelopmental effects on infants from CNS stimulant exposure are not known.

Serdexmethylphenidate is a prodrug of dexmethylphenidate and dexmethylphenidate is the more pharmacologically active d-enantiomer of racemic methylphenidate. There is no information on use of this coformulated drug during lactation. In a limited number of women prescribed methylphenidate for medical indications, the amount of methylphenidate excreted in milk has been found to be low and not detectable in infant serum. It is estimated that a fully breastfed infant would receive a relative dose of 0.2% to 0.7% of the maternal weight adjusted dose. In a study of 7 infants whose mothers received either methylphenidate (average 52 mg/day) or dextroamphetamine (average dose 25 mg/day), no drug-related adverse reactions were reported and normal development for age was observed (average age 4.4 months). Long-term neurodevelopmental effects on infants from stimulant exposure are unknown.

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Further information

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