Dennis O'Brien reports in today's Baltimore Sun that the suicide rates in children and adolescents have increased since 2004, after over a decade of decreases. It was in 2004 that the US FDA decided to add black box warnings to antidepressants stating that they may increase the risk of suicide or suicidal thoughts. Many speculate that the sudden and dramatic increase is related to the 22% decrease in antidepressant prescriptions in this same population.
As noted in our review of a June 2007 AJP article in Podcast #26 (Black Box Reloaded), there was a 58% drop in the expected number of antidepressant prescriptions for kids after the black box was added, while the proportion of depressed children who remained untreated with antidepressants increased some three-fold, going from 20% to 60% (see dramatic graph). At least at last year's FDA hearing, they decided to make a more measured warning, noting that antidepressant medication treatment can be protective and reduce suicidality, as well.
Among people ages 10 to 24, the number of suicides jumped from 4,258 to 4,599 in 2004, the most significant rise in teen suicides in 14 years, according to a report by the Centers for Disease Control and Prevention. That reverses a 28 percent slide in suicide rates for the age group that began in 1990.We also reviewed two other articles (Simon & Savarino and Gibbons et al) about the timing of suicide and treatment in Podcast #30 (Parity Feels Like a Bird). These articles point to increased rates of suicide attempts prior to the initiation of either antidepressant or psychotherapeutic treatments.
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"There's been concern that the black box would lead to a reduction in prescribing and therefore an increase in suicides, and my guess is that's what's happening," said Dr. Mark Riddle, director of child and adolescent psychiatry at the Johns Hopkins Children's Center.
Some doctors are reluctant to prescribe an antidepressant to a child if it comes with the FDA's most stringent warning label, Riddle said: "People see it as a potential feeding frenzy for the malpractice lawyers and it's just scared the clinicians off."
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But other outside experts were reluctant to link the black box warnings with a one-year rise in suicides. . . "There are so many social issues that go into suicide rates and how they're reported."
The September 2007 AJP article by Gibbons et al (a different article than the Gibbons article above) that is mentioned in the Baltimore Sun story provides data on reductions in antidepressant prescriptions by age category since 2004, clearly showing that the reductions are most pronounced in the youngest age groups and become less so with older groups. The only group with an increase in prescription rates is 60 years and older. This is the age group which the FDA has found to be most clearly protected by antidepressant treatment.
The article, entitled "Early Evidence on the Effects of Regulators’ Suicidality Warnings on SSRI Prescriptions and Suicide in Children and Adolescents," concludes with the following warning:
In December 2006, the FDA’s Psychopharmacologic Drugs Advisory Committee recommended that the black box warning be extended to cover young adults, and in May 2007, the FDA asked drug manufacturers to revise their labels accordingly. If the intent of the pediatric black box warning was to save lives, the warning failed, and in fact it may have had the opposite effect; more children and adolescents have committed suicide since it was introduced. If as a result of extending the black box warning to adults there is a 20% decrease in SSRI prescriptions in the general population, we predict that it will result in 3,040 more suicides (a 10% increase) in 1 year (17). If the FDA’s goal is to ensure that children and adults treated with antidepressants receive adequate follow-up care to better detect and treat emergent suicidal thoughts, the current black box warning is not a useful approach; what should be considered instead is better education and training of physicians.