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news.Shire Pharmaceuticals' shares have slipped over 8% on the news that Health Canada stopped sales of the company's ADHD medication, Adderall XR, after the drug was linked to reports of sudden death in adults and children.
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Although Shire is complying with this request to suspend sales, the company strongly disagrees with the conclusions drawn by Health Canada following the product’s labeling update and is considering appropriate responsive action.
The marketing and availability of Adderall XR in the US is unaffected.
Shire stated that it remains confident in the safety and effectiveness of the drug for the treatment of ADHD when used in accordance with the approved labeling. “We are surprised by this action from Health Canada. Shire remains confident in the safety and efficacy of Adderall XR,” commented Matthew Emmens, CEO of Shire.
Adderall XR was approved by Health Canada on January 21, 2004 and launched in February 2004. Approximately 11,000 patients are currently prescribed Adderall XR in Canada and the drug contributed around $10 million of Shire’s annual revenue in its first year on the Canadian market.
The labeling updating with Health Canada was part of Shire’s regular ongoing process of revising the product label with information gathered during the lifetime of the drug.
The interpretation of the same data by the FDA led to a revised US label for Adderall XR in September 2004, clarifying that the drug generally should not be used in children or adults with structural cardiac abnormalities.