Selective Serotonin Reuptake Inhibitors (SSRIs) are a class of antidepressant medications that came on the market in the late eighties and early nineties. SSRIs were found to be clinically effective in treating clinical depression, and anxiety disorders in adults and had less cumbersome side effects compared to the older Tricyclic antidepressants. The first drug in this class introduced was fluoxetine (Prozac), which was soon followed by paroxetine (Paxil), sertraline (Zoloft), citalopram (Celexa), fluvoxamine (Luvox), and escitalopram (Lexapro). Today the uses of SSRIs have broadened to include treatment for “Post-Traumatic Stress Disorder, pre-menstrual dysphoric disorder, urinary incontinence” and many other seemingly unrelated conditions. In North America, “it is estimated that 2% of children and up to 8% of adolescents suffer from a depressive disorder. In addition, at least 10% of youth suffer from anxiety disorders.” Given the prevalence of childhood depression and anxiety disorders, it is not surprising that in the 1990’s and early 2000’s, SSRIs became the treatment of choice in fighting childhood depression and anxiety. Not only were SSRIs prescribed to adolescents and prepubescent children, they were commonly prescribed to kindergarten aged children and even infants less than a year old. However, SSRIs were not clinically tested for use in children and adolescents, nor were they approved for use in children and adolescents. SSRIs were prescribed to children and adolescents “off-label” by physicians, meaning SSRIs had not received approval for use in these age groups by Health Canada. In the first part of the 21st century, concerns began to arise concerning the use of these drugs in children and adolescents as reports began to emerge demonstrating that in many cases SSRIs were associated with an increase in suicidal behavior and thoughts in children and adolescents. Despite being subjected to regulatory warnings from Health Canada and intense media coverage, SSRIs are still widely prescribed to children and adolescents. In this paper, I will review how SSRIs are currently regulated for use as a treatment for depression and anxiety in children and adolescents in Canada by examining the roles of the different actors involved, including: drug manufacturers, regulatory bodies, professional associations, physicians, parents and the patients themselves. In Part II of this paper I will discuss the 2004 warnings issued by regulatory agencies in Canada, the USA and the UK, against the use of SSRIs in children and adolescents; in Part III I will analyze the current off-label status of SSRIs for children and adolescents and the current system used by physicians to prescribe SSRIs to children and adolescents; and in Part IV I will discuss the problems that exist with the current system by examining the roles of each of the abovementioned actors. Finally, in Part V, I will make suggestions as to how the current system can be reformed and improved. The continued off-label use of SSRIs in children is not only dangerous for short-term use in children and adolescents, but could also have dangerous long-term effects as the consequences of SSRIs on child and adolescent development is unknown. The current regulatory system fails to protect this vulnerable population and exposes them to unwarranted and unnecessary risks. A new system is needed in which drug manufacturers are more accountable, regulatory warnings are more forceful, the ability of physicians to prescribe off-label is curtailed, and patients and their parents are more informed about treatment options.
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Kim Wilton, "Risk v Benefits: The Use of Selective Serotonin Reuptake Inhibitors in Children" (2011) 20 Dal J Leg Stud 128.