FDAnews
www.fdanews.com/articles/68996-adderall-sales-suspended-in-canada

Adderall Sales Suspended in Canada

February 21, 2005

Health Canada has suspended the market authorization of Shire Pharmaceuticals' Adderall XR, saying a recent review of Shire safety data revealed an association between the attention-deficit/hyperactivity disorder drug and heart-related deaths and strokes in both children and adults.

The agency said that safety information provided by Shire indicated there have been 20 international reports of sudden death in patients taking either Adderall, which is not sold in Canada, or Adderall XR (amphetamine aspartate). Fourteen of the deaths occurred in children and six in adults, Health Canada said. In addition, 12 incidents of stroke, two of which occurred in children, were reported.

Health Canada also found that the number of serious adverse reactions to Adderall XR and Adderall combined was higher than any other drug in its class.