本帖最後由 Letter_lalaland 於 15-5-31 21:25 編輯
Quoting from Health Canada (加拿大健康局)
http://recherche-search.gc.ca/rGs/s_r?st=s&s5bm3ts21rch=x&num=10&st1rt=0&langs=eng&cdn=health&q=Strattera
http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v18n3-eng.php
ARCHIVED - Canadian Adverse Reaction Newsletter - Volume 18 - Issue 3 July 2008
Atomoxetine and suicidal behaviour: update
Atomoxetine (Strattera) is a selective norepinephrine reuptake inhibitor indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in children 6 years of age and over, adolescents and adults.Footnote1 In September 2005, following the marketing of the drug in February 2005, a Dear Health Care Professional letter was issued regarding the potential for behavioural and emotional changes, including the risk of self-harm,Footnote2 with the use of atomoxetine. The Warnings and Precautions section of the Canadian product monograph was updated to include the following statement: "Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type of emotional and behavioural changes, and clinical worsening."Footnote1,Footnote2
As of Dec. 31, 2007, Health Canada received 189 reports of adverse reactions (ARs) suspected of being associated with the use of atomoxetine. Fifty-five ARs were classified as suicide attempt. According to the World Health Organization Adverse Reaction Terminology (WHOART), the term "suicide attempt" also encompasses "non-accidental overdose," "suicide," "suicidal tendency" and "thoughts of self-harm." Reports involved 41 children (aged 6 to 17 years) and 12 adults (aged 18 to 45); the age was not provided in 2 reports. Of the 55 patients, 29 recovered without sequelae, 3 had not yet recovered at the time of reporting, 1 patient died, and the outcome was not stated in 22 reports.
Treatment options for ADHD include the non-stimulant atomoxetine and stimulants such as methylphenidate and mixed amphetamines.Footnote3 Suicide-related behaviours have been reported with stimulant-type treatments for ADHD.Footnote4 Treatment is complex because patients with ADHD often have other psychiatric disorders.Footnote5 Many studies have found that over 50% of individuals diagnosed with ADHD also meet the diagnostic criteria for one or more additional psychiatric disorders (e.g., mood, anxiety, learning or behaviour disorders).Footnote6 When ADHD is comorbid with other psychiatric disorders, it is often the first disorder to develop, and children with severe symptoms of ADHD are at increased risk of developing other psychiatric disorders.Footnote5 Health care professionals should remind patients, family members and caregivers to monitor moods, behaviours, thoughts and feelings when ADHD medications are used.
Heather Morrison, BSc, MLIS, Health Canada
FootnotesFootnote 1Strattera (atomoxetine capsules) [product monograph]. Toronto: Eli Lilly Canada Inc; 2007. Return to footnote1referrer Footnote 2Warning for atomoxetine regarding the potential for behavioural and emotional changes, including risk of self-harm [Dear Health Care Professional letter]. Ottawa: Health Canada; 2005 Sept 28. (accessed 2008 Jun 3). Return to footnote2referrer Footnote 3Eiland LS, Guest AL. Atomoxetine treatment of attention-deficit/hyperactivity disorder. Ann Pharmacother 2004;38(1):86-90. [ PubMed] Return to footnote3referrer Footnote 4Strandell J, Star K. Reports of suicide related behaviour with methylphenidate and atomoxetine in children and adolescents [poster presentation P.080]. Drug Saf 2007;30(10):919-90. Return to footnote4referrer Footnote 5Kunwar A, Dewan M, Faraone SV. Treating common psychiatric disorders associated with attention-deficit/hyperactivity disorder. Expert Opin Pharmacother 2007;8(5):555-62. [ PubMed] Return to footnote5referrer Footnote 6Brown TE. Attention-deficit disorders and comorbidities in children, adolescents and adults. Washington (DC): American Psychiatric Press; 2000.
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