FDA Tries To Protect Children From Anti-Depressant Risks

By Jeff Freedman

The Food & Drug Administration (FDA) has been cracking down on a pandemic problem involving children and anti-depressants that has had lethal consequences involving children taking mood-elevating drugs. Late last year, the FDA ordered that all antidepressants carry "black box" warnings that they "increase the risk of suicidal thinking and behavior" in children who take them. The reason for this is that, on average, two-to-three percent of children taking the antidepressants Wellbutrin, Paxil, Lexapro, Effexor, Zoloft and Fluoxetine have suicidal ideation or thoughts of suicide.

"We continue to believe, however, that these drugs provide significant benefits for pediatric patients when used appropriately," said Dr. Lester Crawford, acting FDA commissioner. "Antidepressants increase the risk of suicidal thinking and behavior ... in children and adolescents with major depressive disorder and other psychiatric disorders," the warning begins. Those risks must be balanced against clinical need, the label indicates in a warning surrounded by a black box, hence the "black box" disclaimer.

Short of an outright ban, a "black box" warning is the most aggressive warning the FDA can issue. Several of the FDA panel members who made the decision said they hope it would discourage drug companies from advertising antidepressants to patients, especially through television. The FDA rulings came at the end of two days of hearings and question and answer sessions in Bethesda, where the FDA is located. Experts were told about a new FDA analysis of 24 antidepressant trials that showed that children taking a range of drugs had twice the rate of suicidal behavior and thinking compared with those who took placebos.

The panel had to address the fact that depression is associated with suicide, and many specialists believe anti-depressant drugs reduce the risk.

While there is no conclusive evidence to support this claim, studies have shown that suicide rates dropped among populations of children as the prescribing of antidepressants increased. Some experts believe the medications, many of which belong to a specific classification of drugs called selective serotonin reuptake inhibitors, or SSRIs, may increase the risk of suicide among some children while reducing it in others.

"If there were no SSRIs, would there be more suicides, fewer suicides or the same number of suicides in children?" panel member Norman Fost, professor of pediatrics and bioethics at the University of Wisconsin Medical School, asked at the start of yesterday's session.

Robert J. Temple, the FDA's associate director for medical policy, said there are no data to answer that question.

The preponderance of panelists agreed that the enthusiasm for the drugs among American physicians was not supported by the research. Many noted with concern that with the exception of Prozac, none of the antidepressants have been approved by the FDA for treating depression in children. Most children are prescribed the medications "off label" -- based on physicians' belief that the drugs are safe and effective. Once a drug is allowed to be sold on the market, physicians can use it for conditions not specifically approved by the agency.

The panel's recommendation, on a 15 to 8 vote, left the FDA in the position of having to warn physicians about using the drugs for purposes that the agency has not approved.

Researchers claim the problems with children taking these drugs stems from the fact that most antidepressants were not created for children. Instead, physicians prescribe them for "off-label" use. This means that although the drugs have not been systematically studied for safety and effectiveness in treating depression in children or adolescents, doctors still give them to patients based on experience and knowledge of the applicability and efficacy of the drug. Currently, Only Prozac is approved to treat some forms of depression in children. Zoloft is approved for obsessive compulsive disorder in children.

Learn more ways to help a troubled teen struggling with depression at www.about-teen-depression.com and www.adolescent-mood-disorders.com

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