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Label Changes for:

Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules

October 2008

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View


Sections Modified


  • Pregnancy
    • There are no adequate and well controlled studies of Focalin in pregnant women. Dexmethylphenidate did not cause major malformations in rats or rabbits; however, it did cause delayed skeletal ossification and decreased postweaning weight gain in rats. Focalin XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus...
  • Labor and Delivery (new subsection)
    • Focalin XR has not been studied in labor and delivery.
  • Nursing Mothers
    • ...Information from 4 published case reports on the use of racemic methylphenidate during breastfeeding suggest that at maternal doses of 35-80 mg/day, milk concentrations of methylphenidate range from undetectable to 15.4 ng/mL. Based on these limited data, the calculated infant daily dose for an exclusively breastfed infant would be about 0.4 – 2.9.9 μg/kg/day or about 0.2-0.7% of the maternal weight adjusted dose.
  • Geriatric Use (new subsection)
    • Focalin XR has not been studied in the geriatric population.