Pharmaceutical Business review

Shire cleared to re-release ADHD drug in Canada

The drug was withdrawn amid concerns around the deaths of 20 people who were taking the drug.

However, the suspension will now be lifted after Health Canada accepted the recommendation to re-instate the drug made by the New Drug Committee (NDC), which was appointed by Health Canada to review the February 9, 2005 decision to withdraw Adderall XR.

As part of the re-instatement of Adderall XR the NDC recommended that letters should be sent to healthcare professionals to reinforce their understanding of the issues around sudden/cardiac death in the general pediatric population.

“Adderall XR is a safe and effective treatment for people diagnosed with ADHD, and Shire is very pleased that this medicine will once again be available for patients in Canada,” said Shire CEO Matt Emmens. “We appreciate the work of the NDC, and we are gratified that Health Canada accepted their recommendations.”