Canada. Health Canada is allowing Shire BioChem Inc.'s mixed-salts amfetamine preparation containing neutral sulfate salts of dextroamfetamine and amfetamine (Adderall XR) back on the Canadian market following a recommendation from the independent New Drug Committee, who reviewed the suspension of the sale of the drug. Health Canada says that, in accordance with the Committee's recommendations, it will allow the product (Adderall XR) to be reintroduced after steps have been taken, including the revision of the product's prescribing and patient information to reinforce the safe use of the drug and to highlight the safety concerns associated with its use (including the risk of sudden cardiac death in paediatrics).

Shire BioChem Inc. has been recommended to issue a ´Dear Health Professional' letter that advises of the drug's associated risks, and to support independent continuing medical education for Canadian physicians to strengthen their understanding of issues regarding sudden/cardiac death in paediatrics. Health Canada also states that the agency is committed to enhancing post-marketing surveillance of all stimulants used for attention deficit hyperactivity disorder management, and that Shire BioChem Inc. will be requested to provide the agency with regular safety information. (Readers may recall that in February 2005, Health Canada instructed Shire BioChem Inc. to withdraw their amphetamine preparation (Adderall) due to safety information concerning sudden deaths, heart-related deaths and strokes in children and adults receiving recommended doses of the agent. See WHO Pharmaceuticals Newsletter No. 2, 2005).

Reference:

Dear Health-care Professional' letter from Shire Biochem Inc., 31 August 2005 (http://www.hc-sc.gc.ca).