Psychiatr News March 2, 2007
Volume 42, Number 5, page 1
© 2007 American Psychiatric Association
Impact of FDA Warning Questioned in Suicide Rise
Jim Rosack
The data are disturbing—child and adolescent suicides rose from
2003 to 2004 after a decade of steady declines. What caused the
increase?
The number of suicides of youth under age 20 made a dramatic leap from 2003
to 2004, representing an increase of 18.2 percent. Many experts are
questioning whether the increase is tied to a contemporaneous steep decline in
antidepressant prescriptions filled for this population that began after the
Food and Drug Administration issued its first strong warnings about the drugs'
links to increased suicidality in March 2004.
The increase is especially noticeable because "intentional
self-harm," as the federal Centers for Disease Control and Prevention
(CDC) defines the category, was the only cause of death for those under the
age of 20 to increase in rate between the two years.
The suicide rate was disclosed in a report by researchers at the CDC's
National Center for Health Statistics published in the February
Pediatrics.
The increase in suicide deaths paralleled a 20 percent drop in the number
of prescriptions written for antidepressant medications for patients under age
19. That decline occurred amid a media frenzy during 2003 concerning a series
of U.S. Food and Drug Administration (FDA) advisory committee meetings and
Congressional hearings regarding data possibly linking antidepressant
medications with an increased risk of suicidal thoughts and behaviors compared
with placebo (Psychiatric News, September 2, 2005).
In October 2004 the FDA required manufacturers of all antidepressants
marketed in the United States to add a strongly worded black-box warning on
the drugs' labels. APA, as well as many mental health clinicians and
researchers, believes that the new warning, which did not appear on drug
labels until spring 2005, scared a large number of prescribers and parents of
children with depression away from antidepressant medications. Now, some
experts are questioning whether the downturn in prescribing could be directly
linked to the increased number of suicides.
"This is very disturbing news," said David Fassler, M.D., an
APA trustee-at-large and a child and adolescent psychiatrist in Vermont.
"The current data suggest that the decreased use of these medications
is, in fact, associated with an increase in actual deaths attributable to
suicide."
David Shern, Ph.D., president and CEO of Mental Health America, echoed
Fassler's concern.
The addition of the black-box warning to antidepressants' labeling and the
media attention surrounding it, Shern said in a prepared statement,
"have created yet another formidable barrier to treatment for
youth—by scaring young people and parents away from care—and
contributing to a decline in treatment. Without treatment, suicide is a real
risk."
The federal government, he concluded, "must move aggressively to
comprehend any potential consequences of [its] actions on the lives of
youth."
The CDC's researchers reported that the suicide rate for those aged 1 to 19
in 2003 was 2.2 suicides per 100,000 population, equating to 1,737 deaths. The
rate rose to 2.6 per 100,000 in 2004, equating to 1,985 deaths, an increase of
18.2 percent over the prior year (see chart on page 1).
The suicide rate for youth aged 10 to 14 increased 8.3 percent from 2003 to
2004, from 1.2 per 100,000 (244 suicides) to 1.3 per 100,000 (283 suicides).
The rate for those aged 15 to 19 increased 12.3 percent in that same period,
from 7.3 per 100,000 (1,487 suicides) to 8.2 per 100,000 (1,700 suicides).
The FDA did not respond by press time to requests from Psychiatric
News for input on this story.
A preliminary report of the suicide data was discussed at a public meeting
of the Psychopharmacological Drugs Advisory Committee in December
(Psychiatric News, January 19) during consideration of a newly
released meta-analysis of suicidal thoughts and behaviors among adults in
clinical trials of antidepressants.
The FDA meta-analysis found an elevated risk of suicidal thoughts and
behaviors in young adults, up to about age 25 or 30. The advisory committee
members, however, seemed most concerned over the possibility that the new
data, again linking antidepressant medications to an increased risk of
suicidality, could cause more fear and result in more patients' not taking
medically necessary medications. The advisory committee urged the FDA to seek
more balance in the labeling of antidepressant medications by not only
discussing the risks associated with taking the medication, but also pointing
out that untreated depression itself is a major cause of suicide.
An abstract "Annual Summary of Vital Statistics: 2005"
is posted at
<http://pediatrics.aappublications.org/cgi/content/abstract/119/2/345>.
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Psychiatr News 2007 42: 28-35.
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Psychiatr News 2007 42: 4.
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