Atomoxetine labeling

Sexual dysfunction Atomoxetine appears to impair sexual function in some patients. Changes in sexual desire, performance, and satisfaction are not well assessed in most clinical trials because they need special attention and because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate the actual incidence. 

Spencer, X, Biederman, J., Heiligenstein, J., Wilens, X, Paries, D., Prince, J., Earaone, S.V., Rea, J., Witcher, J., and Zeras, S. (2001) An open-label, dose-ranging study of atomoxetine in children with attention deficit hyperactivity disorder. J Child Adolesc Psychopharmacol 11 ... 

Additionally, current product labeling contains a boxed warning regarding an increased risk of suicidal ideation in children and adolescents. Pooled analyses of 12 short-term atomoxetine trials showed an average risk of suicidal ideation of 0.4% in patients taking atomoxetine, compared with none in patients receiving placebo (Strattera 2005). Patients should be advised of the risks associated with atomoxetine prior to treatment. 

Kratochvil CJ, Bohac D, Harrington M, et al An open-label trial of atomoxetine in pediatric attention deficit hyperactivity disorder. J Child Adolesc Psychopharmacol 11 167—170, 2001... 

Kratochvil CJ, Heiligenstein JH, Dittmann R, et al Atomoxetine and methylphenidate treatment in children with ADHD a prospective, randomized, open-label trial. J Am Acad Child Adolesc Psychiatry 41 776-784, 2002... 

Table 2.3 Atomoxetine (STRATTERA ) label recommendations in patients defined by various intrinsic and extrinsic factors [21],...

Extrinsic or Atomoxetine Atomoxetine Atomoxetine intrinsic factors AUC labeling... 

Johnson M, Cederlund M, Rdstam M, Areskoug B, Gillberg C. Open-label trial of atomoxetine hydrochloride in adults with ADHD. J Atten Disord 2010 13(5) 539 5. 

Adler LA, Spencer TJ, Williams DW, Moore RJ, Michelson D. Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD final report of a 4-year study. J Atten Disord 2008 12(3) 248-53. 

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