• Should children and teens take antidepressants?

    June 2008 

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    Since 2004, selective serotonin reuptake inhibitors (SSRIs) have carried a black box warning from the Food and Drug Administration (FDA) about the increased risk for suicide in pediatric patients taking the drugs. More recently, the FDA expanded the warning for young adults ages 18 to 24.

    The FDA has stopped short of banning antidepressants for these age groups and in fact the warning label states that “depression and other serious psychiatric disorders are themselves associated with increases in the risk of suicide.”


    “The new black-box warning is clearly an attempt to balance the small risk posed by antidepressants against their well-documented benefits,” a June 7, 2007, editorial in the New England Journal of Medicine states. “But this new label has the potential to confuse both patients and physicians.” 


    Risk/benefit analysis

    After the 2004 warning, antidepressant usage among children declined, and for the first time in years the Centers for Disease Control and Prevention noted a slight increase in suicide among youth. A 2007 study, funded in large part by pharmaceutical manufacturer Eli Lilly and Company, found that the FDA’s 2004 advisory is associated with a significant reduction in diagnosis and treatment of pediatric depression. According to the study, which appeared in the June 2007 American Journal of Psychiatry, prescriptions for SSRIs for children fell nearly 30 percent after the black-box warnings were implemented.

    A new comprehensive study conducted by researchers at the University of Pittsburgh Medical Center concluded that the benefits of SSRIs outweigh the risks of youth suicides. Their findings appeared in the April 18, 2007, issue of JAMA (Journal of the American Medical Association). The researchers analyzed data on 5,310 children and teenagers from 27 trials of pediatric major-depressive, obsessive-compulsive and non-OCD anxiety disorders. Their research included several recent studies that weren’t part of the 2004 FDA analysis. The studies were randomized and placebo controlled. The antidepressants included Prozac®, Paxil®, Zoloft®, Celexa®, Lexapro®, Effexor®, Serzone® (no longer available in the United States), and Remeron®.

    Suicidal thoughts or behaviors

    The effectiveness of the drugs was measured using rating scales. Like the FDA, the Pittsburgh researchers looked for evidence of increased suicidal thoughts, preparatory actions toward imminent suicidal behavior and actual suicide attempts. There were no suicides in any of the studies.

    They found a slight increase - less than 1 percent - in suicidal behaviors or attempts associated with antidepressant treatment. The FDA found a 2 percent increase.

    Another FDA study, released May 2, 2007, used a much more comprehensive set of data - nearly 100,000 participants age 18 to 24 in 372 randomized trials. The agency found a less than 2 percent increase in suicidal thoughts and behaviors among those taking SSRIs.


    “Some may argue that any risk of suicidal ideation/suicide attempt cannot possibly justify treatment with antidepressants for children and adolescents,” the authors of the Pittsburgh study stated. “Instead, we believe that the strength of evidence presented here supports the cautious and well-monitored use of antidepressant medications as one of the first-line treatment options.” 


    Where antidepressants work best

    According to their findings, antidepressants have the greatest efficacy for children and teens when used to treat anxiety. They are somewhat useful in the treatment of obsessive-compulsive disorders but less effective in treating depression, particularly in young children.

    Other significant findings were these:

    • Teens respond better than children to treatment for depression and anxiety. Among depressed children younger than 12, Prozac was the only antidepressant that worked better than a placebo.
    • On antidepressants, 61 percent of patients studied improved compared to 50 percent who improved taking a placebo.
    • On antidepressants, 52 percent of the young patients with obsessive-compulsive disorders improved compared to 32 percent on placebos.
    • On antidepressants, 69 percent of those suffering anxiety disorders improved compared to 39 percent who improved on the placebo.

    Study limitations

    None of the studies analyzed by the FDA or the University of Pittsburgh examined suicidal thoughts or behaviors as an outcome. Careful screening excluded patients at risk for suicide. The data come from trials to assess the short-term efficacy of antidepressants, not the long-term safety. Additionally, other adverse effects of the drugs such as mania, irritability or agitation were not assessed.

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Page last updated: 5/21/2014 10:37:03 AM
  • What the news means for you

    Benefits of antidepressants often outweigh risks

    Neelkamal Soares, MD, FAAP
    Developmental-Behavioral Pediatrician

    Wright, Heather, MDThe 2004 “Treatment for Adolescents with Depression Study” (TADS) demonstrated that use of fluoxetine (generic Prozac®) was more effective than cognitive behavior therapy alone, combination of the two was most effective, and either was more effective than placebo. The April 2007 Pittsburgh study also concluded that benefits of antidepressant use outweigh risks in the treatment of children and adolescents with depression. It reviewed antidepressant use, sometimes off-label, in other childhood mental health conditions, including obsessive-compulsive disorder and other anxiety disorders, and demonstrated a lower risk of suicidal thoughts than the FDA analysis.

    Another study found that suicide rates in children and adolescents from 1996 to 1998 were actually lower in areas with higher rates of SSRI prescription fills, although no causal relationship could be determined. The greatest risk of untreated, or inadequately treated, depression is suicide, which is the third leading cause of death among 15- to 24-year-olds (CDC 2005), accounting for 12.9 percent of all deaths annually in this age group.

    Side effects of SSRIs

    All medications, including antidepressants, carry some risk of side effects. Typical side effects include gastrointestinal issues (nausea, vomiting, diarrhea), central nervous system issues (headaches, dizziness, insomnia, somnolence), sexual dysfunction (reduction of libido), and activation (increased activity, agitation, restlessness). In patients with bipolar or mood disorder, SSRI use may activate them to a manic state.

    Suicidal thoughts and behaviors

    An important fact to note in the FDA warnings and the studies they were based on: No suicides were recorded in 24 studies of more 4,400 patients and the FDA did not ban any of the medications. Recent findings confirm the long-held belief of prescribers familiar with antidepressants that soon after the initiation of treatment (in studies, the first nine days) is the critical period for increased risk of suicidal behavior. The best hypothesis is that as people recover from depression their risk of suicide is increased early as the medications provide more activation before addressing suicidal thoughts; thus depressed individuals may have more energy to act on their thoughts.

    Antidepressant medication prescribing practices since “black box warning”

    The FDA warnings appeared to have slowed a longer-term sustained national increase in the prescription of antidepressant medications (from 1985-99, a four-fold national increase). National rates of diagnosing new-onset pediatric depression increased 25 percent between 1999 and 2004. Prior to the FDA’s advisory, rates of diagnoses made by pediatricians and primary care physicians steadily increased and accounted for the majority of the new diagnoses. After the advisory, rates of diagnosis significantly decreased by this group and significantly increased among psychiatrists. Antidepressant prescription rates among primary care physicians reversed significantly after the advisory. Prescription rates also decreased for psychiatrists, even though they tend to treat more severe patients and presumably have greater knowledge of antidepressants.

    Burden on physician providers

    In addition to the black-box warning for SSRIs, the FDA required mandatory distribution of a medication guide with each antidepressant prescription and issued specific monitoring guidelines. These guidelines stated that the clinician should follow up with weekly face-to-face visits for the first four weeks of antidepressant treatment initiation, biweekly visits for the next four weeks, and then a monitoring visit four weeks later.

    This has created a significant burden to the health care system in two ways. First, apprehension among primary care providers with limited time to adhere to the recommendations and fear of litigation has led the primary care physicians to increase referrals to specialists and reduce their direct involvement in the prescribing of antidepressants. Second, the increase in volume for already scarce child/adolescent psychiatrists and developmental-behavioral pediatricians with long waiting lists has led to many not adhering to the recommendations in their entirety.

    Barriers to mental health access

    There continues to be a stigma among many families about mental health issues that reduces their likelihood of seeking prompt care for these conditions. Additionally, the great distances many communities have to traverse to access the few subspecialists located mainly at tertiary care centers with long wait lists reduce access and continued compliance with care. The fact that primary care providers in their own communities have reduced writing prescriptions has further compounded the access problem.

    A resource for families

    An excellent publication available free from the National Alliance on Mental Illness is What Families Should Know About Adolescent Depression and Treatment Options, available at www.nami.org.

    Dr. Neelkamal Soares is a board-certified developmental-behavioral pediatrician, and assistant professor of pediatrics and family & community medicine. His areas of interest are autism spectrum disorders, medical education in child development, and telemedicine to provide consultation on children and adolescents with developmental, behavioral and learning problems throughout Kentucky.

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