Methylphenidate Pregnancy and Breastfeeding Warnings
Methylphenidate Pregnancy Warnings
Methylphenidate has been assigned to pregnancy category C by the FDA. Adequate animal reproductive studies to establish the safe use of methylphenidate during pregnancy have not been conducted. There are no controlled data in human pregnancy. However, in the Michigan Medicaid Birth Defects Study involving 229,101 pregnancies from 1985 to 1992, there was one major cardiovascular birth defect reported out of 13 newborns who were exposed to methylphenidate during the first trimester. (One was expected.) (Written communication, Franz Rosa, MD, Food and Drug Administration, 1994) Methylphenidate is only recommended for use during pregnancy when benefit outweighs risk.
Methylphenidate Breastfeeding Warnings
In another case report, following a maternal dose of 5 mg in the morning and 10 mg at noon (immediate-release formulation), the mean milk/serum concentration ratio was 1.1 (range 0.8 to 1.6). The relative infant dose was 0.16% of the weight- adjusted maternal dose and the estimated absolute infant dose was 0.38 mcg/kg/day. Adverse effects were not observed in the infant.
Methylphenidate is excreted into human milk. Adverse effects in the nursing infant are unlikely given a relatively low exposure. In one case, following a maternal daily dose of 40 mg twice daily, the milk-to-plasma ratio was 2.7. The relative infant dose was 0.2% of the weight- adjusted maternal dose and the absolute infant dose was 2.3 mcg/kg/day. Adverse effects were not detected in the infant. Caution is recommended if the drug is to be administered to a nursing woman.
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