FDA Logo--links to FDA home page
U.S. Food and Drug Administration
HHS Log--links to Department of Health and Human Services website

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

horizonal rule

FDA Statement

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 http://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.


Canadian Advisory on Adderall

FDA Public Health Advisory, Patient Information, Health Professional Information, Adderall Labeling

rule Get free weekly updates about FDA press releases, recalls, speeches, testimony and more. rule