A study conducted by investigators at the University of Colorado, in Denver, shows that, following an October 2003 Public Health Advisory issued by the Food and Drug Administration (FDA) about antidepressant use and the risk for suicidality in children and a subsequent extension of the warning to include young adults in May 2007, national rates of new depression diagnoses returned to 1999 levels for pediatric patients and below 2004 levels for adults — with reductions of 44% for children, 37% for young adults, and 29% for adults.
"The fact that FDA policy changed behavior and that this change persisted over time is a major take-home message from this study. In my opinion, this should raise the bar when evaluating the potential impact of such warnings," lead investigator Anne M. Libby, PhD, told Medscape Psychiatry.
The FDA's stated purpose in issuing the warning to was to increase monitoring of children and young adults taking antidepressants, including assessment of suicidality. However, the current study and previous research conducted by Dr. Libby's group show that such monitoring did not increase, but diagnosis and treatment of depression dropped significantly.
"Whether you think these reductions are large or small is a matter of opinion, but I think they are pretty large. This is a prime example of trying to achieve a specific result — increased monitoring — with a broad policy and ending up with an unintended and across-the-board reduction in depression diagnosis and treatment," she added.
The study is published in the June issue of Archives of General Psychiatry.
No Increase in Anxiolytic, Antipsychotic Use
Previous research has shown that the short-term effects of the FDA warnings decreased case findings of pediatric depression and, among new cases, decreased antidepressant prescribing.
However, said Dr. Libby, it was not clear what the long-term impact of the policy was on depression diagnosis; prescriptions of antidepressants, anxiolytics, and antipsychotics; or psychotherapy visits.
To examine these effects, investigators compared post-FDA advisory trends with expected trends by analyzing patterns in a national integrated managed-care claims database from July 1999 through June 2007.
During this period 91,748 children ages 5 to 18 years, 70,311 young adults ages 19 to 24 years, and 630,748 adults ages 25 to 89 years were diagnosed with depression.
Between 1999 and 2004, the rate of diagnosed depression increased steadily in each study group. However, after 2004, the researchers report the national rate of pediatric case findings fell significantly, with the postadvisory decline persisting such that the rate of 3.5 per 1000 enrollees in 2007 approached the 1999 level of 3.2 per 1000 enrollees.
"Based on the historical trend established in the 5 years prior to the advisory, the 2007 rate per 1000 enrollees would have been 15.6 for young adults and 20.3 for adults; the actual observed rate was 9.6 for young adults and 12.4 for adults," the authors write.
The researchers did not find an increase in other forms of treatment, including psychotherapy or use of other psychotropic agents such as anxiolytics or antipsychotics. Dr. Libby described the latter finding as "a good thing."
Spillover Effect in Adults
There was a small but significant increase in the proportion of new depression cases that received at least 1 visit for psychotherapy, but this applied to adults only.
Primary-care clinicians specifically continued to diagnose fewer cases of depression, with a 44% lower rate of diagnosis among pediatric patients, 37% lower among young adults, and 29% lower among adults, who, Dr. Libby noted, were not targeted by the warning.
Dr. Libby said her main concern is that clinicians, mostly primary-care physicians who treat the largest proportion of patients seeking mental healthcare, are simply not treating mental-health problems now, an effect that constitutes "a major step back" in the diagnosis and treatment of this very common mental illness.
The FDA needs to initiate measures to reverse the unintended effects of this particular policy and possibly reevaluate its overall approach to risk communication, said Dr. Libby.
"I've heard FDA officials giving talks, and they've even said it in the press, that if there were evidence that the warnings had large and persistent unintended consequences that they would revisit and reopen the boxed-warning [issue].
"I think this [study] is evidence that the policy effects are persistent and broad and that the policy did things that the FDA didn't intend, so I want them to reconsider the boxed warning," she said.
Furthermore, said Dr. Libby, depression carries an extremely high risk for suicide, and this needs to be weighed against a relatively small potential risk associated with antidepressant use.
Increase in Adolescent Suicides
Asked by Medscape Psychiatry to comment on the study, David Fassler, MD, clinical professor of psychiatry at the University of Vermont, in Burlington, and spokesperson for the American Psychiatric Association, said the findings are not unexpected but are nonetheless a cause for concern.
"This study is consistent with previous findings. It provides further evidence that the FDA’s decision to place black-box warnings on all antidepressants has led to a significant reduction in the diagnosis and treatment of depression in children, adolescents, and adults."
Previous reports, he said, have also documented a significant increase in the adolescent suicide rate since the warning was instituted. "The increase in adolescent suicides corresponds to an average of approximately 300 actual additional deaths per year," said Dr. Fassler.
"By their action, the FDA intended to provide parents and physicians with information about the potential risks and benefits of [selective serotonin-reuptake inhibitor] SSRI antidepressants. However, from a public-health perspective, it appears that the warnings have had unintended and adverse consequences.
"The FDA has an obligation to monitor the impact of their regulatory decisions. In the past, they've suggested that they would consider reconvening the advisory panel when and if warranted by subsequent data and research findings. The results of the current study should clearly be included in any such review," he added.
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