FDA Says It Plans Label Changes for Concerta and
Ritalin
By
Peggy Peck, Senior Editor, MedPage Today
June 29, 2005
Also covered by: LA Times
(Registration Req.), MSNBC, Newsday
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.
Tilbake
til siden ADHD/Ritalin