|
FDA Statement
FOR IMMEDIATE RELEASE
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
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.
Internal link to
Health Canada suspending Adderall
|