FDAnews
www.fdanews.com/articles/68605-canada-withdraws-uk-drugmaker-shire-s-adhd-drug

Canada Withdraws UK Drugmaker Shire's ADHD Drug

February 10, 2005

Canadian health officials have ordered the withdrawal of the Attention Deficit Hyperactivity Disorder therapy Adderall XR from the market. The drug is produced by the UK's third-largest drugmaker, Shire Pharmaceuticals, and has been controversially linked to about 20 fatalities. The company has criticised the decision.

Adderall, described as mixed salts of a single-entity amphetamine product, currently accounts for almost half of Shire's annual revenue of some US$345mn. The withdrawal comes despite a decision by the US FDA to allow sales of the product to continue, albeit with a change in labelling to indicate a risk to patients with heart conditions. The drug has also not been linked to any deaths in Canada, although the US FDA is reported to be liasing with Canadian authorities on their decision.