Amid a steep decline in antidepressant prescriptions for children and
adolescents since regulators mandated label warnings of possible links between
the drugs and suicide risk, psychiatric organizations are urging the Food and
Drug Administration (FDA) to track the impact on patients.
A September 2 letter from APA and the American Academy of Child and
Adolescent Psychiatry (AACAP) alerted the FDA about a new analysis of data on
antidepressant prescription patterns (Psychiatric News, September 2)
and asked that the FDA monitor the impact of the black-box warning on
antidepressants it issued on October 15, 2004.
The analysis, which was done by Psychiatric News reporter Jim
Rosack, was based on a two-year dataset provided to Psychiatric News
in August by NDC Health Inc. It revealed a swift and steep decline in
antidepressant prescriptions dispensed to youth aged 18 and under.
The nearly 20 percent drop in the number of antidepressant prescriptions
dispensed for minors is "a decline whose public health consequences are
unknown and must be monitored by policymakers, physicians, parents, and
patients," said the letter, which was signed by APA President Steven
Sharfstein, M.D., and AACAP President Richard Sarles, M.D., and sent to the
FDA commissioner at the time, Lester Crawford, D.V.M., Ph.D.
"This dramatic shift raises the serious questions of whether those
children and adolescents with depression who are no longer taking these
medications are receiving any care at all—or are receiving the most
effective care," they wrote.
Among the information some child and adolescent psychiatry advocates are
seeking is whether a corresponding increase has occurred in treatments such as
cognitive-behavioral therapy and interpersonal therapy, which have proven
effective with adults.
The prescription data tracked the drop in antidepressant use among
adolescents to the first strong public health advisory from the FDA on the use
of the drugs in youngsters in March 2004 (Psychiatric News, April 16,
2004). Another drop occurred in October 2004, the same month the FDA mandated
a controversial black-box warning for antidepressants (Psychiatric
News, November 5, 2004).
The black-box warning, which must appear on the labeling of all
antidepressant medications distributed in the United States, stated that the
drugs "increase the risk of suicidal thinking and behavior (suicidality)
in children and adolescents with major depressive disorder (MDD) or other
The FDA did not return calls for comment on the APA letter, but an FDA
official had previously told Psychiatric News that the agency"
has not systematically tracked antidepressant prescribing in the
pediatric population since" the warning was added. That decision by the
FDA came despite previous formal requests from both APA and the AMA.
APA first requested that the agency track the impact of the black-box
warning on prescribing patterns on the same day the warnings were mandated.
APA requested a tracking system to identify any increase in actions by
patients to harm themselves as a result of reduced access to medically
necessary treatment with antidepressants. AACAP and the AMA have made similar
Thomas Laughren, M.D., acting director of the FDA Division of Psychiatry
Products in the Center for Drug Evaluation and Research, told Psychiatric
News in his initial response to the newspaper's data analysis that"
even tracking suicidal behavior in this population is not a failsafe
approach to assessing the impact of this labeling change, because secular
trends in such behavior are influenced by many different factors."
In their letter, APA and AACAP pointed out that several studies, including
the Treatment of Adolescents With Depression Study (TADS) funded by the
National Institute of Mental Health, have shown combination treatment
consisting of medication and talk therapy is the most effective for youngsters
with depression. That course of treatment "would appear to be endangered
by such a strong decline in the medication portion of therapy," the
"This shift is additionally disturbing to us because it comes at a
time when we should be doing more to help children and adolescents with
depression, not less," Sharfstein and Sarles wrote, citing
under-treatment of teenagers for depression as noted in "Mental Health:
A Report of the Surgeon General," published in 1999. "The biggest
threat to a depressed young person's well-being is to receive no care at
all," they said.