Did FDA Teen Suicide Warning Backfire?

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Updated: 11/21 11:59 am

Sept. 13, 2007 - Warnings that antidepressants may increase teen suicides appear to have backfired, a new study suggests.

The study shows that a steep drop in antidepressant prescriptions for children and teens followed the FDA and European drug authority warnings. At the same time, there was an unprecedented spike in child and teen suicides.

The study isn't proof that the antidepressant warnings caused the increase in suicides. But the circumstantial evidence -- from both the U.S. and the Netherlands -- is very compelling, says study researcher Hendricks Brown, PhD, director of the prevention science and methodology group at the University of South Florida College of Public Health, Tampa.

"The FDA actions look like they had very serious unintended consequences," Brown tells WebMD. "Our analyses show that the FDA actions, which should have reduced or at least not changed the number of suicides for youth, had just the opposite effect."

On the advice of an expert panel, the FDA in 2004 put a "black-box" warning -- its highest warning level -- on antidepressants for pediatric use. The panel's advice was based not on actual suicides, but on indications that suicidal thoughts and behaviors increased in some children and teens taking newer SSRI-type antidepressants.

It looks as though the FDA effort backfired, says Boris Birmaher, MD, director of the child and adolescent mood and anxiety program at the University of Pittsburgh's Western Psychiatric Institute. Birmaher was not involved in the study.

"Years ago we speculated that suicides -- not suicidal thoughts or suicide attempts but real deaths -- were going down because a lot of doctors, not just psychiatrists, were prescribing SSRI antidepressants," Birmaher tells WebMD. "Then comes the black box, and without any other specific reason there was a huge increase in the number of kids dying from suicide. This is not proof, just a statistical association. But it is suspicious."

Researcher Robert D. Gibbons, PhD, of the University of Illinois, Chicago, was a member of the FDA panel. He voted against the black-box warning.

"The FDA has overestimated the effect of antidepressant medications on suicidality and dramatically underestimated the efficacy of antidepressants in the treatment of childhood depression," Gibbons told WebMD in April 2007.

The study by Gibbons, Brown, and colleagues, appears in the September issue of the American Journal of Psychiatry.

(Have you held off putting your teen on antidepressants because of black box warnings? Talk about it on the Depressed and Bipolar Kids: Family Support message board.)

Antidepressant Use Dropped, Suicides Soared After Warnings

Brown and colleagues looked at antidepressant prescription data in a large sample of American and Dutch pharmacies. They also obtained data on suicide rates from the CDC and from the Netherlands Central Bureau of Statistics.

They found that from 2002 to 2003, prescription rates for SSRI antidepressants went up for all age groups -- continuing a steady increase since 1987. After 2003, prescription rates dropped for all ages under 60.

Then came the warnings:

  • October 2003: The FDA issued a public health advisory warning of reports of children and teens who attempted or committed suicide after taking antidepressants.
  • December 2003: The U.K. and European drug agencies advised doctors not to prescribe most antidepressants for children under age 18.
  • February 2004: The FDA ordered drug makers to put a "black box" warning -- its highest warning level -- on the labels of all antidepressants used in pediatric patients. The label warned of increased risk of "suicidality" in children and teens taking the drugs.
  • December 2006: The FDA extended the black-box warning to young adults.

Here's what happened to antidepressant prescriptions and suicide rates:

  • 1998-2003: U.S. SSRI antidepressant prescription rates went up 91% and suicides dropped 33%.
  • 1998-2003: Netherlands SSRI antidepressant prescription rates went up 120% and suicide rates dropped by 31%.
  • 2003-2004: SSRI antidepressant prescriptions drop 22% in U.S. and Netherlands.
  • 2003-2004: U.S. youth suicides went up 14% (2005 figures not yet available).
  • 2003-2005: Netherlands youth suicides went up 49%.

The one-year 14% increase in suicides among American 5- to 19-year-olds is highly unusual. Since 1988, suicides in this age group went up only twice: a 1% bump in 1994 and a 3% increase in 2000.

If there really is a link between fewer antidepressant prescriptions and child and teen suicides, Brown and colleagues predict that the CDC's statistics will show a 44% increase in child and teen suicides from 2003 to 2005.

The effects aren't limited to kids.

"There is a spillover effect: SSRI prescriptions in the U.S. for all other age groups have been decreasing for everyone under age 60," Brown notes.

If the warnings cut adult antidepressant prescriptions by 20%, the researchers predict that there will be 10% more adult suicides.

Kids Not Getting Depression Treatment of Any Kind

Birmaher notes that there's another disturbing trend going on. Since the black-box warnings, fewer children and teens have been diagnosed with major depression.

"The fact that diagnosis of major depression has decreased means these kids are going untreated. Nobody is offering them anything, neither antidepressants nor psychotherapy," Birmaher says. "This can be linked to the increase in suicides. And unfortunately, this looks like a side effect of the FDA warning."

Birmaher says that depressed kids are at highest risk of suicide in the month before they seek treatment.

"Depression in kids and in grown-ups goes together with suicide, just as strep throat goes together with high fever," he says. "Kids at high risk of suicide are the ones seeking treatment. Once treatment begins, suicidality begins to decrease. This is an important message for the public. If you are not aware of this, you can mix up the cause of suicide -- depression -- with the effect of treatment."

Brown says the findings underscore how important it is for parents to know when their children need support for mental health issues.

"It is important for parents to be able to talk with their children and to learn if their children are feeling like killing themselves," he says. "A conversation like that can be a lifesaver. There is no way to help these kids if they suffer in silence. Asking kids if they are suicidal does not increase their risk of killing themselves, and may actually give them the opportunity to talk about how they are actually feeling."

Both Brown and Birmaher stress that antidepressants and psychotherapy are both effective treatments for depression. They say untreated depression -- not treated depression -- is the true cause of suicide.

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