Reactions 1104 - 3 Jun 2006 Health Canada advises of revised labelling for ADHD drugs According to Health Canada, the prescribing information for all attention deficit hyperactivity disorder (ADHD) drugs has been revised in Canada to include standardised prescribing information that identifies risk factors for cardiac-related adverse events (AEs), and to provide recommendations to reduce these risks. 1,2 This applies to the following drugs and all products containing these drugs: Ritalin [methylphenidate] and Ritalin SR [methylphenidate extended release], which are both manufactured by Novartis Pharmaceuticals Canada Inc, and Adderall XR [SLI 381], Attenade [dexmethylphenidate], Biphentin [methylphenidate], Concerta [methylphenidate], Dexedrine [dexamfetamine], Strattera [atomoxetine], which are manufactured by Shire Pharmaceuticals Group, Bioavail [sic] Pharmaceuticals Canada, Purdue Pharma, Janssen-Ortho Inc, GlaxoSmithKline Inc, and Eli Lilly Canada Inc, respectively. 1 The revisions affect the Dosing recommendations, Contraindications, Warnings and Precautions, and Information for the Patient. Health professionals are advised that ADHD drugs should be started at the lowest dose and increased slowly, and should not be given to patients with a symptomatic heart disorder, advanced arteriosclerosis, hyperthyroidism, moderate to severe hypertension, or structural cardiac abnormalities; 1 further cardiovascular (CV) system evaluation may be considered before starting ADHD drugs in patients with relevant risk factors, and patients who require long-term ADHD drugs should undergo periodic CV status evaluation. Patients are advised to not discontinue ADHD drugs without consulting their doctor, and to inform their doctor if they are using other ADHD drugs, are involved in strenuous activity, have certain heart disorders or a family history of sudden cardiac death, before using these drugs. 2 Health Canada states that, theoretically, a pharmacological potential for all ADHD drugs to increase the risk of sudden/cardiac death exists, 1 but ADHD drugs are generally safe and beneficial when used as directed. 2 See also Reactions 1039 p2; 800999206, 1068 p2; 801013111, and 1089 p3; 800999850 1. Health Canada. Attention deficit hyperactivity disorder (ADHD) drugs: updated and standardized labelling regarding very rare cardiac-related adverse events. Internet Document : [3 pages], 26 May 2006. Available from: URL: http:// www.hc-sc.gc.ca. 2. Health Canada. New cautions regarding rare heart-related risks for all ADHD drugs. Media Release : 26 May 2006. Available from: URL: http://www.hc- sc.gc.ca. 801069043 1 Reactions 3 Jun 2006 No. 1104 0114-9954/10/1104-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Health Canada advises of revised labelling for ADHD drugs

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Reactions 1104 - 3 Jun 2006

Health Canada advises of revisedlabelling for ADHD drugs

According to Health Canada, the prescribinginformation for all attention deficit hyperactivitydisorder (ADHD) drugs has been revised in Canada toinclude standardised prescribing information thatidentifies risk factors for cardiac-related adverse events(AEs), and to provide recommendations to reduce theserisks.1,2 This applies to the following drugs and allproducts containing these drugs: Ritalin[methylphenidate] and Ritalin SR [methylphenidateextended release], which are both manufactured byNovartis Pharmaceuticals Canada Inc, and Adderall XR[SLI 381], Attenade [dexmethylphenidate], Biphentin[methylphenidate], Concerta [methylphenidate],Dexedrine [dexamfetamine], Strattera [atomoxetine],which are manufactured by Shire PharmaceuticalsGroup, Bioavail [sic] Pharmaceuticals Canada, PurduePharma, Janssen-Ortho Inc, GlaxoSmithKline Inc, and EliLilly Canada Inc, respectively.1 The revisions affect theDosing recommendations, Contraindications, Warningsand Precautions, and Information for the Patient.

Health professionals are advised that ADHD drugsshould be started at the lowest dose and increasedslowly, and should not be given to patients with asymptomatic heart disorder, advanced arteriosclerosis,hyperthyroidism, moderate to severe hypertension, orstructural cardiac abnormalities;1 further cardiovascular(CV) system evaluation may be considered beforestarting ADHD drugs in patients with relevant riskfactors, and patients who require long-term ADHDdrugs should undergo periodic CV status evaluation.Patients are advised to not discontinue ADHD drugswithout consulting their doctor, and to inform theirdoctor if they are using other ADHD drugs, are involvedin strenuous activity, have certain heart disorders or afamily history of sudden cardiac death, before usingthese drugs.2

Health Canada states that, theoretically, apharmacological potential for all ADHD drugs toincrease the risk of sudden/cardiac death exists,1 butADHD drugs are generally safe and beneficial whenused as directed.2

See also Reactions 1039 p2; 800999206, 1068 p2;801013111, and 1089 p3; 8009998501. Health Canada. Attention deficit hyperactivity disorder (ADHD) drugs: updated

and standardized labelling regarding very rare cardiac-related adverse events.Internet Document : [3 pages], 26 May 2006. Available from: URL: http://www.hc-sc.gc.ca.

2. Health Canada. New cautions regarding rare heart-related risks for all ADHDdrugs. Media Release : 26 May 2006. Available from: URL: http://www.hc-sc.gc.ca.

801069043