Pill Identifier App

Methylphenidate Pregnancy and Breastfeeding Warnings

Methylphenidate is also known as: Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Quillivant XR, Ritalin, Ritalin LA, Ritalin-SR

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.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.