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FDA Says It Plans Label Changes for Concerta and Ritalin

Ƶ MedicalToday

WASHINGTON, June 29-The FDA said today it plans to strengthen the warning label for Concerta, the popular long-acting version of Ritalin (methylpenidate) in response to reports of psychiatric and cardiovascular adverse effects.


An FDA advisory panel meeting here today and tomorrow was reviewing proposed labeling recommendations.


A statement posted on the FDA website, reflecting reports from post-marketing surveillance, listed visual hallucinations, suicidal ideation, psychotic behavior, and aggressive or violent behavior as side effects of Concerta and other methylphenidate products.


Cardiovascular side effects included "hypertension, chest pain, prolong QTc arrhythmias, and tachycardia," according to the FDA statement. But it added that it "is not yet possible to determine whether these events, especially the more serious ones, are causally related to these treatments."


The FDA also noted that last year it required Adderall XR to amend its label to include a warning about sudden cardiovascular deaths, especially in children.

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