Adderall: Canadian Regulators Order ADD Drug Withdrawn

From a recent news story – Drug withdrawal weighs on Shire:

Shares in Shire Pharmaceuticals have fallen 10% after its best-selling drug was withdrawn from sale in Canada amid reports linking it to 20 sudden deaths.

Regulators said data showed 14 children and six adults had died after taking the usual recommended doses of hyperactivity treatment Adderall XR.

Shire said it disagreed with the findings and remained confident in the safety and effectiveness of the drug.

The Hampshire-based firm is the UK’s third largest pharmaceutical company.

Most sales of Adderall XR come from the US.

The US FDA has also issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market.

Adderall XR (amphetamine)
Audience: Neuropsychiatric and other healthcare professionals

FDA issued a Public Health Advisory to notify healthcare professionals that Health Canada, the Canadian drug regulatory agency, has suspended the sale of Adderall XR in the Canadian market. Adderall XR is a controlled release amphetamine used to treat patients with Attention Deficit Hyperactivity Disorder (ADHD). The Canadian action was based on U.S. post-marketing reports of sudden deaths in pediatric patients. FDA is continuing to evaluate these and other post-marketing reports of serious adverse events in children, adolescents, and adults being treated with Adderall and related products. Adderall XR is approved in the United States for the treatment of adults and pediatric patients 6-12 years old with ADHD, and Adderall, the immediate release formulation of the drug, is approved for pediatric patients with ADHD.

More information can be found on the FDA Adderall and Adderall XR Information page.

FDA ALERT [2/09/2005] – Sudden Deaths in Children

Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR.  SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR.  In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall.  At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data.

More information can also be found on the FDA Patient Information Sheet: Adderall and Adderall XR Extended-Release Capsules and the Alert for Healthcare Professionals: Adderall and Adderall XR (amphetamine).