Article issued in WebMD Health News on Feb. 10, 2005
Twelve sudden deaths in American kids taking Adderall have led Canada to suspend sales of the drug.
Adderall is an amphetamine drug used to treat children and adults with ADHD -- attention deficit hyperactivity disorder. It's sold in the U.S. in an immediate-release form and, as Adderall XR, in an extended-release form.
The FDA is not following the lead of Health Canada, the Canadian drug regulatory agency. After seeing the same reports in August 2004, the FDA at that time merely agreed to a label change for Adderall XR. That change made it clear that Adderall XR should not be given to patients with heart defects.
"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," a Feb. 9 FDA statement says.