David Baxter PhD
Late Founder
New Information About The Risks of Suicidal Behavior in Youth Taking Antidepressants
Natalie Staats Reiss, Ph.D.
Mon, Apr 30th 2007
A new study published in the Journal of the American Medical Association (JAMA, April 18 2007) sheds additional light on the debate about using antidepressant medication in children and adolescents.
In October 2003, the U.S. Food and Drug Administration (FDA) issued a public health advisory, warning of an increased risk of suicidal behavior or suicidal ideation (thinking about killing oneself or wanting to be dead) among children and adolescents who were taking antidepressant medications. One year later, after a comprehensive review of available research, the FDA required manufacturers of all antidepressant medications to put a warning about this potential for increased suicidal behavior on the boxes of these drugs. According to the FDA, a class of medications known as selective serotonin reuptake inhibitors (SSRIs) are particularly risky for children and adolescents. Approximately 4% of the 4,400 children taking SSRIs (such as Prozac and Paxil) had suicidal ideation or attempts, twice the rate of children taking a placebo (a pill with no active ingredients). In other words, two out of every 100 children experienced suicidal ideation or made suicide attempts. However, no children in the study were recorded as "completed" suicides. In 2006, an advisory committee recommended that the FDA extend the "black box warning" to include young adults up to age 25.
Not surprisingly, the FDA warning decreased the use of SSRIs in children and adolescents. Although over-prescribing antidepressants and over-medicating youth is inappropriate, many health care professionals worry that the FDA label adversely affects children and adolescents who could potentially benefit from these medications. Parents may also worry about children who are already taking these antidepressants, and wonder whether this medication is putting their children in danger.
The recent study published in JAMA suggests that the risks of antidepressant medications for young children and adolescents may be lower than previously reported by the FDA. The JAMA study authors reviewed 27 published and unpublished studies (5,310 participants) of antidepressants in children and adolescents younger than 19 for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder (OCD) and other anxiety disorders. In the JAMA review, one out of every 100 youth treated with antidepressants had suicidal ideation or attempts. Again, in this study, there were no completed suicides.
The JAMA study also found that antidepressants were most successful in controlling non-OCD anxiety disorders, followed by OCD and then MDD. In addition, Prozac was the only antidepressant effective in treating depression for children under 12. The authors of the JAMA study concluded that the benefits of antidepressants (such as decreasing the symptoms of anxiety or depression) outweigh the risks in children and adolescents.
Even with this new information, the debate about the risks and benefits of using antidepressant medication in youth will continue. Part of the problem that prohibits drawing a clear conclusion comes from limitations with how we study the effects of drugs on people. For example, it is very difficult to take group study data and predict how a particular antidepressant will affect a certain child or adolescent. Most drug studies are highly controlled research with a very specific type of participant, so the conclusions may not apply to everyone. Many studies are too small to allow us to predict very rare events, such as suicide, with statistical confidence. Also, the groups in these studies often do not include youth who have a high risk of suicidal behavior already. As a result, we probably don't know what happens to these people when they take antidepressants. It is also incredibly difficult to tease out the true risk of the drugs, because psychological disorders (particularly depression) are themselves risk factors for suicidal behavior.
As a result, the decision about the appropriateness of using antidepressant medication with children must be made on a case by case basis. A parent should be aware of the potential benefits and risks of the medication being considered, and work closely with health care professionals to determine an appropriate treatment plan. If therapy includes taking SSRI medications, closely monitor children for any worsening in depression symptoms (sadness, crying, irritability, anger, feeling discouraged or worthless, fatigue, drop in school performance, inability to sit still, fidgeting or pacing, change in eating habits, etc.), the presence of suicidal thinking or behavior, or any unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations. Close monitoring is especially important during the first four weeks of treatment.
Natalie Staats Reiss, Ph.D.
Mon, Apr 30th 2007
A new study published in the Journal of the American Medical Association (JAMA, April 18 2007) sheds additional light on the debate about using antidepressant medication in children and adolescents.
In October 2003, the U.S. Food and Drug Administration (FDA) issued a public health advisory, warning of an increased risk of suicidal behavior or suicidal ideation (thinking about killing oneself or wanting to be dead) among children and adolescents who were taking antidepressant medications. One year later, after a comprehensive review of available research, the FDA required manufacturers of all antidepressant medications to put a warning about this potential for increased suicidal behavior on the boxes of these drugs. According to the FDA, a class of medications known as selective serotonin reuptake inhibitors (SSRIs) are particularly risky for children and adolescents. Approximately 4% of the 4,400 children taking SSRIs (such as Prozac and Paxil) had suicidal ideation or attempts, twice the rate of children taking a placebo (a pill with no active ingredients). In other words, two out of every 100 children experienced suicidal ideation or made suicide attempts. However, no children in the study were recorded as "completed" suicides. In 2006, an advisory committee recommended that the FDA extend the "black box warning" to include young adults up to age 25.
Not surprisingly, the FDA warning decreased the use of SSRIs in children and adolescents. Although over-prescribing antidepressants and over-medicating youth is inappropriate, many health care professionals worry that the FDA label adversely affects children and adolescents who could potentially benefit from these medications. Parents may also worry about children who are already taking these antidepressants, and wonder whether this medication is putting their children in danger.
The recent study published in JAMA suggests that the risks of antidepressant medications for young children and adolescents may be lower than previously reported by the FDA. The JAMA study authors reviewed 27 published and unpublished studies (5,310 participants) of antidepressants in children and adolescents younger than 19 for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder (OCD) and other anxiety disorders. In the JAMA review, one out of every 100 youth treated with antidepressants had suicidal ideation or attempts. Again, in this study, there were no completed suicides.
The JAMA study also found that antidepressants were most successful in controlling non-OCD anxiety disorders, followed by OCD and then MDD. In addition, Prozac was the only antidepressant effective in treating depression for children under 12. The authors of the JAMA study concluded that the benefits of antidepressants (such as decreasing the symptoms of anxiety or depression) outweigh the risks in children and adolescents.
Even with this new information, the debate about the risks and benefits of using antidepressant medication in youth will continue. Part of the problem that prohibits drawing a clear conclusion comes from limitations with how we study the effects of drugs on people. For example, it is very difficult to take group study data and predict how a particular antidepressant will affect a certain child or adolescent. Most drug studies are highly controlled research with a very specific type of participant, so the conclusions may not apply to everyone. Many studies are too small to allow us to predict very rare events, such as suicide, with statistical confidence. Also, the groups in these studies often do not include youth who have a high risk of suicidal behavior already. As a result, we probably don't know what happens to these people when they take antidepressants. It is also incredibly difficult to tease out the true risk of the drugs, because psychological disorders (particularly depression) are themselves risk factors for suicidal behavior.
As a result, the decision about the appropriateness of using antidepressant medication with children must be made on a case by case basis. A parent should be aware of the potential benefits and risks of the medication being considered, and work closely with health care professionals to determine an appropriate treatment plan. If therapy includes taking SSRI medications, closely monitor children for any worsening in depression symptoms (sadness, crying, irritability, anger, feeling discouraged or worthless, fatigue, drop in school performance, inability to sit still, fidgeting or pacing, change in eating habits, etc.), the presence of suicidal thinking or behavior, or any unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations. Close monitoring is especially important during the first four weeks of treatment.
