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FDA STATEMENT

FOR IMMEDIATE RELEASE
February 9, 2005

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


 

Statement on Adderall

FDA is aware of Health Canada’s decision to suspend sales, but not revoke the approval in Canada, of the drug Adderall as a treatment for Attention Deficit and Hyperactivity Disorder (ADHD). FDA has been in close consultation with the Canadian authorities regarding the basis for their action. FDA does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analyses of adverse event reports and FDA’s own knowledge and assessment of the reports received by the agency.

FDA is issuing a Public Health Advisory and information sheets on its website at www.fda.gov in order to address questions that may arise from the Canadian announcement and to provide up-to-date information about Adderall’s safety profile.

Patients using Adderall (or parents of children on the drug) who have questions about this medication should consult their physicians before making any alterations to their therapy.

As with any drug, FDA will continue to carefully assess any new data that emerges which significantly affects the safety profile of this drug and will take immediate, appropriate action to promote the public health and make the public aware of its findings.

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