Amphetamine salts suspended.(Regulatory Action)

Canada -- Health Canada has suspended marketing of amphetamine salts (Adderall XR[R]) for attention deficit hyperactivity disorder (ADHD) with effect 9 February 2005.

The decision to withdraw amphetamine salts is founded on very rare, international, spontaneous reports of sudden deaths in paediatric and adult patients. Reports for death include those for patients taking usual recommended doses, including recommended starting doses. In a minority of cases, the events occurred on the first day of dosing or shortly after an increase in dose or a switch from another drug in the structural class. Deaths were reported for patients both naive or chronically exposed to …