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David Baxter

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FDA black-box warnings may have increased teen suicide rate
Saturday, 8 September 2007

A new study by researchers at the University of South Florida and University of Illinois suggests FDA mandated warnings about suicide in teens treated with antidepressants could have the unintended consequence of placing more youth at risk.

When a possible connection was suggested between teens who take antidepressant medications and a higher suicide rate, Hendricks Brown, professor and director of the Prevention Science and Methodology Group, USF College of Public Health, decided to investigate along with his colleague Robert Gibbons from the University of Illinois at Chicago.

The researchers report findings contrary to earlier studies suggesting a link between antidepressants and suicidal thinking and behavior in youth.

"The overall effect of these newer antidepressants is very likely that they reduce suicide risk considerably," Brown said. "Overall, the new antidepressants provide a large protective benefit. If there is any group of people who are adversely affected by taking these antidepressants, it has to be a very small group."

The findings are compelling, especially in view of the FDA's requirement in May for major black-box warnings to be placed on antidepressants for youth and young adults that advise of a potential suicide risk. The warnings, in turn, have led to a marked reduction in antidepressant use in adolescents and adults.

Suicide is the third leading cause of death in adolescents in this country, following only unintentional injuries and homicide. In real numbers, about 30,000 young people take their own lives in America each year.

These overwhelming figures, in addition to his own experiences with families who had lost loved ones to suicide, motivated Brown to devote enormous efforts to the study of teenage suicide prevention.

"People need to know if the antidepressant medication they are taking is increasing or decreasing their risk for suicide," Brown said. "It would be bad if antidepressants were causing an increase in suicides, in which case the appropriate policy would be to restrict their use in adolescents. It would be even worse if FDA policies led to less treatment of depression and more suicides."

Brown and his group examined different statistical approaches that might assess whether a widely used class of antidepressants known as selective serotonin reuptake inhibitors (i.e., Prozac, Zoloft, Paxil, Celexa) were causing more or less suicides in the teenage population.

The analysis was problematic because suicide occurs in one person out of 10,000 youth, but there were only a few thousand youth enrolled in all the clinical trials of antidepressants. And in none of these trials was there a suicide, either among those given an antidepressant, or those given an inactive placebo. There was no ability to compare rates because the number of subjects in the clinical trials was too small.

Given those limitations, Brown used several data sources where depressed individuals were treated differently with different classes of antidepressants or no medication, and he examined the rates of suicide along with the rates of antidepressant prescriptions at the county level. He also looked at the reports of suicide detailed by U.S. doctors after medication use.

Brown found that suicide attempts were dramatically lowered once antidepressant medication began, indicating an overall benefit of these newer medications. Also, very few people who died from suicide had been taking antidepressants.

He also found consistent reductions in suicide across counties as well as across countries during the time when there was increased use of antidepressants. Now that the overall level of antidepressants have decreased since the FDA warnings, there is very early evidence of an upturn in youth suicides (Centers for Disease Control data released this week shows that suicide rates in under 25s rose 8% in the year after black box warnings were mandated by the FDA).

"With the FDA warnings there has been a rapid lowering of antidepressant prescriptions, and there has been a corresponding increase in youth suicides" noted Brown. "We found similar results in the Netherlands once the warning was broadcast there as well."

Brown said sometimes health policy decisions are made on limited information, and it may be that the FDA warnings about suicide in youth treated with antidepressants could have unintended consequences of placing more youth at risk. The FDA is now reviewing policy decisions in the light of these data and at some point may withdraw or revise its warning.

Brown's other work involves some of the first rigorous evaluations of additional therapies and corresponding successes of teenage suicide prevention, including community-based prevention plans. One such program, Sources of Strength, was developed in North Dakota and appears to be very helpful for rural, underserved communities and Native-American communities.

"There are valuable treatments available and ways that people can cope and thrive with adversity, rather than just survive in this world," Brown said. "There are ways for people who have suicidal thoughts and attempts to get help."

SOURCE: Gibbons RD, Brown CH, Hur K, et al. Early Evidence on the Effects of Regulators' Suicidality Warnings on SSRI Prescriptions and Suicide in Children and Adolescents Am J Psychiatry 2007 164: 1356-363 [Abstract]

COMMENT: There is evidence that Professor Brown's concern that the FDA warning could lead to "less treatment of depression and more suicides," has occurred. A study by Anne Libby and colleagues from the University of Colorado at Denver found that while antidepressant prescribing for new cases of adolescent depression halved, there was no significant increase in alternative treatments. It seems the children (and their parents) were basically left to fend for themselves. So recent reports of dramatic increases in suicidality after 15 years of steady falls are not surprising.
 

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