Inpharma 1503 - 3 Sep 2005

Adderall XR allowed back on theCanadian market

Health Canada is allowing Shire BioChem Inc’sAdderall XR [SLI 381] back on the Canadian marketfollowing a recommendation from the independent NewDrug Committee, which reviewed the suspension of thesale of the drug.

Health Canada says that, in accordance with thecommittee’s recommendations, it will allow Adderall XRto be reintroduced after steps have been taken,including the revision of Adderall’s prescribing andpatient information to reinforce the safe use of the drugand to highlight the safety concerns associated withAdderall’s use (including the risk of sudden cardiacdeath in paediatrics). Health Canada says that ShireBioChem Inc has been recommended to issue a ‘DearHealth Professional’ letter that advises of Adderall’sassociated risks, and to support independent continuingmedical education for Canadian physicians tostrengthen their understanding of issues regardingsudden/cardiac death in paediatrics. Health Canada alsostates that the agency are committed to enhancing post-marketing surveillance of all stimulants used forattention deficit hyperactivity disorder management,and that Shire BioChem Inc will be requested to providethe agency with regular safety information; furthermore,the agency is advising patients to consult theirphysicians about the use of Adderall XR.Health Canada. Health Canada allows Adderall XR® back on the Canadianmarket. Media Release : 24 Aug 2005. Available from: URL: http://www.hc-sc.gc.ca 809053505

» Editorial comment: In February this year, Health Canadainstructed Shire BioChem Inc to withdraw Adderall due to safetyinformation concerning sudden deaths, heart-related deaths andstrokes in children and adults receiving recommended doses ofthe agent [see Inpharma 1475: 20, 19 Feb 2005; see Inpharma1475 p20; 800999206].

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Inpharma 3 Sep 2005 No. 15031173-8324/10/1503-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved