Label Changes for:
Concerta (methylphenidate HCl) Extended-Release Tablets
June 2008
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 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. Read about the new physician labeling format. |
| Sections Modified | Summary of Changes to Contraindications and Warnings |
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CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
PATIENT COUNSELING INFORMATION
MEDICATION GUIDE
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CONTRAINDICATIONS Hypersensitivity to Methylphenidate Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with Concerta. Therefore, Concerta is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product... WARNINGS AND PRECAUTIONS Psychiatric Adverse Events Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder... |
