Poster Presentations
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ABSTRACTS
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Poster Presentations P.080 Reports of Suicide Related Behaviour with Methylphenidate and Atomoxetine in Children and Adolescents J. Strandell, K. Star The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden Background: Methylphenidate and atomoxetine are indicated for treatment of Attention Deficit Hyperactivity Disorder (ADHD) of children 6 years and adults. The Summary of Product Characteristics contains warnings of suicide related behaviour for atomoxetine[1] and worsening of suicide related behaviour with methylphenidate. In the literature there are indications of increased risk of suicidal behaviour with high doses. Aim: To analyse the reports of the children and adolescents reported with suicidal behaviour in VigiBase. Method: VigiBase were scrutinised for suspected adverse drug reaction (ADR) reports with the preferred WHO-ART term[2] ‘suicide attempt’ and its ‘included terms’ with methylphenidate/atomoxetine. Since atomoxetine and methylphenidate are mainly used in young individuals, the review focused on patients up to 17 years. Results: VigiBase revealed 327 reports of atomoxetine (n = 244) and methylphenidate (n = 116) and ‘suicide attempt’ in patients from 5 to 17 years of age. In 33 reports atomoxetine and methylphenidate were coreported. The number of reports per WHO-ART ‘included term’ among the 5-11 year olds by drug (atomoxetine/methylphenidate) were as follows: depression suicidal (n=4/1), intentional overdose (n=1/-), intentional self-injury (n=12/3), non-accidental overdose (n=1/1), suicidal tendency (n=75/32), suicide (n=1/-), suicide attempt (n=13/19), thoughts of self harm (n=2/1). The corresponding numbers among the 12-17 year olds were: depression suicidal (n = 2/-), intentional overdose (n=6/2), intentional self-injury (n=15/8), non-accidental overdose (n=13/8), suicidal tendency (n = 82/21), suicide (n=10/7), suicide attempt (n=36/25), thoughts of self harm (n=-/-). Four patients were under the labeled age. 17 patients committed suicide and additionally one patient died. 78 patients were reported to be depressed, of which 17 were administered antidepressants. Additionally, 42 patients were treated with antidepressants. Six patients had doses greater than the recommended.[1] Conclusion: The number of reports with suicidal behaviour in children and adolescents raises concern. The reports do not only imply possible suicidal behaviour: young patients actually commit suicide. Additional concern is the usage among too young children. Amphetamine was previously used in ADHD treatment, and has been suggested to cause of suicidal behaviour. This might cause reporting bias for any drug used within the same therapeutic area including methylphenidate and atomoxetine. Among the VigiBase reports, higher than recommended doses were sometimes recorded, in these cases the reported suicidal behaviour might indicate the occurrence of an ADR or imply a non-accidental overdose. Benefits/risks o
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