Benefit should outweigh risk

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Published studies and postmarketing reports are insufficient to inform a drug-associated risk of of major birth defects, miscarriage, or adverse pregnancy-related outcomes; based on animal data, this drug may cause fetal harm.

Comments:
-No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of this drug during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
-There is a US pregnancy registry that monitors pregnancy outcomes in women exposed to psychostimulants during pregnancy; healthcare providers are encouraged to register patients with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388

In rabbits, teratogenic effects (increased fetal spina bifida) were observed at approximately 40 to 60 times the maximum recommended human dose (MRHD). In rats, an increased incidence of fetal skeletal variations was seen at 7 to 11 times the MRHD; this dose was also maternally toxic. CNS stimulants such as this drug are known to cause vasoconstriction which would decrease placental perfusion. A limited number of human pregnancies have been reported, however, due to lack of detail regarding dose and duration of exposure, concomitant use of other medications, and other factors which may have affected outcomes, these cases cannot establish or exclude drug-associated risks. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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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Limited data have shown low levels of this drug in breastmilk; published reports estimate infants would receive 0.16% to 0.7% of the maternal weight-adjusted dose. This drug was undetectable (less than 1 mcg/L) in the blood of 2 breastfed infants whose mothers took an average of 52 mg/day. 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).

This drug reduces serum prolactin, but the prolactin level in a mother with established lactation may not affect her ability to breastfeed. No information is available on the effect of this drug on milk production.

Benefit should outweigh risk

Excreted into human milk: Yes

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.
-Some authorities advise against maternal use during breastfeeding for safety reasons.

See references