A recent survey of clinicians, including psychiatrists, in Nebraska has
directly connected the Food and Drug Administration's (FDA's) warning on
antidepressants to their reluctance to prescribe antidepressants to treat
children and adolescents with
Although several studies based on prescription databases have recorded flat
or declining trends in antidepressant use after the FDA issued its black-box
warning about increased risk of suicidal thoughts and behaviors in children
and adolescents, these data could not establish a causal relationship or clear
association for the decline. Supriya Bhatia, a fourth-year medical student and
faculty members at the University of Nebraska Medical Center (UNMC), conducted
a survey of physicians and other prescribing clinicians, including nurse
practitioners and physician assistants. The survey was mailed in July 2005,
less than a year after the black-box warning was issued, to 1,521 prescribing
clinicians in Nebraska based on the clinician database in the Health
Professionals Tracking Center at UNMC and other supplemental sources. A total
of 866 clinicians responded, resulting in a response rate of 57.5 percent.
Among the survey respondents were 122 psychiatric clinicians, 139 pediatric
clinicians, and 605 family medicine clinicians who practiced in various
clinical settings in both urban and rural areas of Nebraska. Almost all (97
percent) of the respondents said they were aware of the warning.
The psychiatric clinicians included 65 general psychiatrists, 20 child and
adolescent psychiatrists, and 37 residents, specialized nurse practitioners,
and physician assistants.
Before the FDA warning, 80 percent of the responding clinicians in family
medicine, 69 percent of responding pediatric clinicians, and 71 percent of
responding psychiatric clinicians reported that they were prescribing
antidepressants to children and adolescents. After the black-box warning, 16
percent of the respondents said they decreased prescribing antidepressants for
children, and 37 percent said they decreased prescribing for adolescents.
About 5 percent stopped prescribing antidepressants for young patients.
"We found it a bit startling that so many clinicians just stopped
treating child and adolescent depression altogether or decreased treatment
after the warning," said Bhatia, the study's first author, in an
interview with Psychiatric News.
About half (49 percent) of the respondents said they were "moderately
comfortable" or "comfortable" in prescribing antidepressants
to children and adolescents; 8 percent said they felt "very
In response to the black-box warning, half of the clinicians in family and
pediatric medicine said they began to refer more young patients to specialists
such as psychiatrists, psychologists, and clinical social workers, for
treatment of depression.
About 32 percent of respondents, or 276 clinicians, reported more frequent
contacts, either by telephone or in office, with young patients upon
initiating antidepressant treatment after the black-box warning. The survey
did not ask clinicians why they did not see patients more often or follow the
FDA's recommendation of weekly follow-up. Bhatia suggested that limited access
to care—especially in rural areas of Nebraska—lack of insurance
reimbursement, and patients' lack of resources are possible factors for the
"Despite widespread knowledge of the black-box warning, only 7.5
percent of the clinicians responding to the survey reported following the
initial FDA guidance of weekly monitoring throughout the first month after
initiating treatment with an antidepressant," Christopher Kratochvil,
M.D., an associate professor of psychiatry at the UNMC and the senior author
of the study, commented to Psychiatric News. The FDA later removed
this monitoring guideline from antidepressant labeling.
More than 20 percent of the respondents said they had encountered at least
one caregiver or patient who had refused an antidepressant prescription
because of the much-publicized black-box warning.
"[Our survey] highlights the importance of patient and parent
education, accompanied by open discussion, in order to facilitate adherence,
safety, and optimal patient care," said Kratochvil. "It is
essential that the patient, parents, and clinician work together as a team in
treating depression in children and adolescents."
The survey was funded in part by the Spurlock Minority Medical Student
Fellowship of the American Academy of Child and Adolescent Psychiatry.
Both authors pointed out that this survey has tackled a new perspective in
the unresolved question regarding the effect of the FDA's black-box warning on
treatment for children and young adults with major depression.
"There have been a lot of published data from insurance claims data
and national trends, but we were able to get clinicians' response on a more
personal basis," said Bhatia. She and her colleagues were"
pleasantly surprised" by the 58 percent response rate to this
"Antidepressant Prescribing Practices for the Treatment of
Children and Adolescents" is posted at<www.liebertonline.com/doi/pdfplus/10.1089/cap.2007.0049>.▪