BACKGROUND ON THE ISSUES

Suicide is a serious, yet tragically underrecognized, public health problem that claims approximately 30,000 lives each year in the United States. Cast in its societal and historical context, the rate of suicide for the past century has been two to three times that of homicide. Worse yet, suicide is one of the foremost causes of death among children and young adults (IOM, 2002). Depression and other mood disorders confer the highest risk of suicide (Fawcett et al., 1991; Goodwin and Jamison, 2007; Harris and Barraclough, 1997). It has been estimated that 35 to 50 percent of depressed children make a suicide attempt, and 2 to 8 percent commit suicide over a 10-year period (Fombonne et al., 2001; Kovacs et al., 1993; Rao et al., 1993; Weissman et al., 1999).

Given the severity of the problem, the public health profession, after decades of effort, has developed successful programs to reduce suicide among high-risk groups (Brown et al., 2005; Guzzetta et al., 2007; Knox et al., 2003; Lauterbach et al., 2008; Rutz et al., 1989, 1992; Szanto et al., 2007). Meanwhile, the public health profession also has wrestled, since 1991, with the controversial possibility that the very medications given to combat depression and other mood disorders paradoxically may contribute to the risk of suicide ideation (i.e., suicidal thinking) and suicidality (i.e., suicidal attempts, preparatory behaviors, or suicide completions) in a minority of cases. Researchers and regulators began in earnest to examine the evidence systematically through randomized and controlled trials.

As more data and analysis came to light in 2004, the FDA issued its first set of warnings by calling attention to an increased risk of suicidality among children and adolescents taking antidepressants. The FDA required that labeling of specific antidepressants carry black box warnings, intended to alert physicians and patients to increase monitoring of troubling symptoms. One concern at the time was the surge in antidepressant prescriptions by primary care physicians with insufficient oversight of patients (IOM, 2002). The United Kingdom’s drug regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA), used its Committee on Safety of Medicines to explore the issue in 1998 and eventually banned the use of antidepressants3 for children and adolescents with mild cases of depression. In 2003, the MHRA stated that “on the basis of this review of the available clinical trial data, CSM has advised

3

All antidepressants were banned in 2003, except for fluoxetine (Prozac), for use in children and adolescents by the Medicines and Healthcare Products Regulatory Agency.



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