Psychiatr News October 5, 2007
Volume 42, Number 19, page 1
© 2007 American Psychiatric Association
Suicide Data Prompt Call for Black-Box Review
While authors of a new study acknowledge that there is no proven
connection between an increase in youth suicides and a decrease in
antidepressant prescriptions, they believe the coincidence of the phenomena is
See Youth Suicides on Rise—Question Is Why?
The number of suicides among children and adolescents rose dramatically at
the same time that the number of prescriptions for antidepressant medications
fell, following public health warnings from the U.S. Food and Drug
Administration (FDA) about a putative association between suicide and
In addition, the same pattern of rising suicide and declining
antidepressant prescriptions for children and teens was seen in the
These findings, which were reported in the September American Journal
of Psychiatry (AJP), have APA leaders calling for the FDA to reconsider
its advisory about antidepressant use, including a black-box warning the
agency placed on antidepressants in 2004.
In the United States 1,737 suicides by children aged 5 to 19 were recorded
in 2003; in October of that year the FDA issued its first public health
advisory regarding several reports of children and teenagers taking
antidepressants who attempted or committed suicide (see Youth Suicides on
Rise—Question Is Why?).
The following year, 1,985 suicides were recorded in the same age group,
representing a 14 percent increase, the largest year-to-year change in
suiciderates in this population since the Centers for Disease Control and
Prevention (CDC) began systematically collecting suicide data in 1979,
according to the AJP report (Psychiatric News, March 2).
The FDA followed its initial health warning with another one in February
2004, and in October 2004 the administration ordered pharmaceutical companies
to add a black-box warning to the labeling of all antidepressants used with
pediatric patients regarding a possible increased risk of suicidality in
pediatric patients taking antidepressants.
It was during this period of concern about antidepressant use and
suicide—while youth suicides were rising—that prescriptions for
selective serotonin reuptake inhibitors (SSRIs) decreased for all patients
under age 60, with the decline being greatest for the youngest patients: from
2003 to 2005 prescriptions for children age 0-14 declined approximately 20
percent overall and 30 percent for new prescriptions, according to
Though much of the AJP report cited statistics specific to SSRIs,
Gibbons and colleagues also looked at patterns of non-SSRI antidepressant
prescribing and found the same decreases.
"Although some might expect that decreases in SSRI prescriptions
would have led to increases in alternative antidepressant treatments, such as
the newer nonserotonergic-specific antidepressants and tricyclic
antidepressants, this does not appear to have been the case," the
authors wrote. "Similar decreases were seen in pediatric and young-adult
prescription rates for both these alternative antidepressant types
(approximately 20 percent in the 5–14 years age range and approximately
10 percent in the 15–19 years age range)."
Though there is no proof of a causal association between rising suicide
rates and declining antidepressant use, the study authors believe the
coincidence of the two phenomena is compelling.
"Our study represents an analysis of a frightening natural
experiment," Robert Gibbons, Ph.D., director of the Center for Health
Statistics at the University of Illinois, told Psychiatric News.
"The results are not encouraging. More data are needed, and we are
working with CDC to analyze data on suicide for 2005 to verify this
"But we have clearly shown that there has been a substantial decrease
since the early public health advisory in 2003 and the black-box warning in
2004 in antidepressant prescriptions for children," Gibbons said.
"During this same period, there has been a record increase between 2003
and 2004 in teen and child suicides.
"This is unprecedented. An increase of 14 percent is monumental. It
is the largest change of any kind in these statistics since the CDC started
monitoring youth suicide. And it is by far the largest increase in teen and
child suicide since the introduction of antidepressant medication."
Data on 2005 suicides among youth are expected to be released later this
year, said Gibbons, a professor of biostatistics and professor of psychiatry
at the University of Illinois at Chicago.
The data on suicides for the report in AJP were from the CDC's
Web-based Injury Statistics Query and Reporting System (WISQARS).
Following publication of the AJP article, the CDC—in a weekly
Morbidity and Mortality Weekly Report (MMWR) issued in the second week of
September—reported statistics from the same WISQARS database on trends
in youth suicide for a different age group (10 to 24 years). That report found
an 8 percent increase in suicide in that age group from 2003 to 2004 (see
Youth Suicides on Rise—Question Is Why?).
The alarming confluence of increasing suicides and decreasing
antidepressant prescriptions has leaders in child psychiatry calling for the
FDA to reconsider the advisory and black-box warnings.
"It is definitely time for the FDA to revisit the black-box language
in light of these findings," said APA President Carolyn Robinowitz, M.D.
"The AJP report documents the considerable decline in treatment
following the FDA's imposition of the black-box label, and the 14 percent
increase in suicides in youngsters under 19 after more than a decade of
Robinowitz emphasized that, in contrast, there were no suicides in the
studies that had originally prompted the FDA's black-box decision. And she
drew attention to the fact that the AJP report and CDC figures were
issued in time for National Suicide Prevention Week, September 9 to 15.
"Education is so important in raising awareness about suicide
prevention and treatment," she said.
David Mrazek, M.D., chair of APA's Council on Children, Adolescents, and
Their Families, echoed Robinowitz's comment about no suicide deaths in the
studies leading up to the FDA advisory warnings. "This is the really
poignant part," he said, "that on the basis of an analysis in
which there were no suicides, the FDA made a decision that now seems to be
very probably linked to actual suicides.
"From a public health as well as a clinical perspective, I hope that
the FDA will promptly convene a group to examine these data and consider the
consequences of this warning."
Mrazek is chair of the Department of Psychiatry and Psychology at the Mayo
Clinic in Rochester, Minn.
The last time that antidepressant labeling and medication guides were
updated was this past summer in response to recommendations made by the
Psychopharmacologic Drugs Advisory Committee at the end of 2006. The committee
called for language to reflect the risk of suicide associated with untreated
depression in children and young adults up to age 24 and the danger associated
with untreated depression. The updated information now includes the statement,
"Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide."
Responding to an information request from Psychiatric News, an FDA
press officer said the administration was not considering a change in the
"At this time nothing indicates a need for change in the black-box
warning on these drugs, which urges attention to patients starting
treatment—still good advice—and does not suggest avoiding the
drugs," the press officer stated. "We have not at all tried to
discourage use of antidepressant drugs in depressed children, just remind
people of the care needed.
"We are anticipating the new adolescent suicide data (2004 to 2005)
that should become available later this year. We expect that other data will
also have accumulated at that point—newer suicide data from other
countries, other epidemiologic data pertinent to suicidality, newer use data
for antidepressants, and possibly additional efficacy data. It will be
important to assess all available data together."
Several lines of evidence appear to support the association between a rise
in youth suicide and the decline in antidepressant prescriptions. Among these
is the fact that the same pattern observed among American youth by Gibbons and
colleagues in the AJP report was also found among youth in the
There, where suicide data are available through 2005, the researchers found
that the SSRI prescription rate declined by 22 percent for patients under age
20, while the suicide rate increased by 49 percent between 2003 and 2005.
Further supporting the association is the finding that suicides for people
aged 60 and over in the United States reached a record low in 2004. Meanwhile,
SSRI prescriptions increased between 2003 and 2005 by 15 percent for this age
group, the only age group to experience an increase in being prescribed an
antidepressant after 2003 and the time of FDA's public health warnings.
All of these indicators point to an ominous conclusion.
"While these data do not provide a causal link, they are extremely
suggestive," Gibbons said. "These are ecological data, but I
haven't heard any other hypothesis [that explains the increase in suicides]
that is credible."
In the September AJP report, annual U.S. antidepressant
prescription rate data for 2003–05 by ZIP code were drawn from a random
sample of 20,000 pharmacies from the 36,000 pharmacies in the database of IMS
Health in Plymouth Meeting, Pa., which represents over half of all retail
pharmacies in the continental United States.
Though the database does not include hospital prescriptions, the
investigators used data from the National Ambulatory Medical Care Evaluation
Survey and the National Hospital Ambulatory Medical Care Evaluation Survey to
compute the ratio of hospital to nonhospital prescriptions for SSRIs by year;
they found that the IMS Health data account for nearly 90 percent of SSRI
prescriptions in the United States.
Data on national suicide rates in the Netherlands from 1998 to 2005 for
children up to age 15 and teenagers aged 15 to 19 came from the Central Bureau
of Statistics. Prescription data in the Netherlands were obtained from the
PHARMO database at
The database consists of a representative sample of more than 200 pharmacies
in more than 50 regions representative of the Netherlands.
The study was supported by NIMH. Prescription data were obtained from IMS
Health with the assistance of a grant-in-aid from Pfizer. Pfizer was not
involved in the research and did not review the results or the manuscript
prior to submission.
"Early Evidence on the Effects of Regulators' Suicidality
Warnings on SSRI Prescriptions and Suicide in Children and Adolescents"
is posted at
The MMWR report is posted at
Youth Suicides on Rise—Question Is Why?
- Rich Daly
Psychiatr News 2007 42: 4.
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American Psychiatric Association.
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