When the Food and Drug Administration (FDA) warned clinicians that
antidepressants may increase the risk of suicidality in pediatric patients in
2003, the agency also urged clinicians to closely monitor patients, especially
those who are started on these medications, for signs of suicidal ideation.
The evidence suggests, however, that the recommendation is often not followed.
Patients who were put on antidepressants did not seem to receive more vigilant
care from their health care providers, according to a study published in
AJP in Advance on November 6.
The effect of the FDA public health advisory and subsequent black-box
warning for all antidepressants received extensive attention in the lay media,
and clinical practice changes followed. The number of patients, including
children and adults, taking these medications has declined ever since
(Psychiatric News, September 7, 2007).
Researchers from the University of Colorado at Denver and University of
Pittsburgh analyzed a large managed care claims database to determine how
frequently patients on antidepressants visited their health care providers
between October 1998 and March 2005. They compared visit patterns with the
depression-treatment standards recommended by the National Committee on
Quality Assurance's Health Plan Employer Data and Information Set (HEDIS)
There were no statistically significant changes in the percentage of
pediatric patients who had received "optimal practitioner
contacts" before and after October 2003, when the FDA issued the
antidepressant advisory. The percentage of adult patients who had follow-up
visits as recommended was even lower than that for
The HEDIS metric defines optimal practitioner contacts as at least three
contacts with care providers in the first 12 weeks after the initial
antidepressant prescription. Billable telephone contacts were considered a
"We had expected some change in the intensity of monitoring after the
FDA's advisory," said Robert Valuck, Ph.D., a coauthor of the study."
We were surprised by the findings given the immediate and accelerated
drop in the diagnosis and overall treatment of depression and all the media
attention and scrutiny."
The same group of researchers had found that after the FDA advisory was
issued in 2003, fewer diagnoses of depression were made and, for those who
were diagnosed with new episodes of depression, any treatment decreased as
well (Psychiatric News, August 3 and September 7). They found no
compensatory increase in treatment alternatives such as psychotherapy to
accompany the plunge in antidepressant prescriptions.
Meanwhile, it appears that patients who were prescribed antidepressants in
this period did not receive more frequent care from their treatment providers
despite the FDA's recommendations. "Our data don't answer why," he
said. The authors suggested a number of possibilities, including obstructed
access to care, logistical difficulties in arranging for more frequent visits,
and insurance-plan restrictions.
The HEDIS quality indicators were derived from expert consensus on clinical
practice; the depression-specific indicators have been tracked since 1998.
This study found that the quality of follow-up care for patients newly
diagnosed with depression, at least in terms of contact frequency between
clinicians and patients, did not change significantly after the FDA warnings
about increased suicide risk.
The FDA recommended a more intensive schedule (seven visits in the first
three months) of follow-up care in a medication guide released in 2003. This
recommendation was removed in a revision to the guide earlier this year after
psychiatrists complained about the lack of clinical evidence to support this
Trends in follow-up care remained consistently flat across specialties. The
study authors found that more psychiatrists kept up with antidepressant
monitoring compared with other types of providers. About 80 percent of
pediatric patients seen by psychiatrists had follow-up visits that met the
HEDIS standard, a percentage higher than those seen by pediatricians (60
percent) and primary care physicians (54 percent). However, changes in the
rates of meeting the HEDIS optimal practitioner contact standard before and
after October 2003 were not statistically significant within each provider
type, indicating a lack of influence on practice by the FDA advisory.
Included in the analyses were more than 27,000 pediatric patients and
193,000 adult patients in the managed care claims database who had a new
episode of depression and received antidepressant medication within 30 days of
the diagnosis. A new episode of depression was defined as having no
depression-related diagnosis during the 120 days before the diagnosis and no
antidepressant prescription claims during the 90 days before. "We have a
robust dataset that is representative of national managed care populations and
trends in clinical practice," said Valuck.
According to data recently released by the Centers for Disease Control and
Prevention, suicide rates among youth increased by 8 percent from 2003 to
2004, which paralleled the drop in antidepressant prescriptions after the FDA
warning (Psychiatric News, October 5). The public health effects of
the mandated black-box warnings for antidepressants are still hotly
"Frequency of Provider Contact After FDA Advisory on Risk of
Pediatric Suicidality with SSRIs" is posted at<ajp.psychiatryonline.org/cgi/reprint/appi.ajp.2007.07010205v1>.▪