Knowledge Means Power

Adderall XR

Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6 years of age and older with Attention Deficit Hyperactivity Disorder (ADHD). Canada has suspended the sale of Adderall XR in the Canadian market. The Canadian action was based on reports of sudden deaths in pediatric patients using the drug. The Food and Drug Administration (FDA) is aware of these and evaluated the risk of sudden death with Adderall XR prior to approving the drug for adults last year.

Of 12 total fatalities reported, five occurred in patients with underlying structural heart defects which already increase the risk of sudden death. The FDA is evaluating these and other reports of serious adverse events in children, adolescents, and adults being treated with Adderall XR, however it does not appear that the FDA will take any regulatory action at this time.

The labeling for Adderall XR was changed in the United States in August 2004 to include a warning that patients with the structural heart defects might be at risk, and should ordinarily not be treated with Adderall XR.

Posted: Aug 31 2009, 03:43 PM by digitalangel | with no comments
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