Impact of Label Warnings Felt Beyond Target Groups

Robert Valuck, Ph.D., an associate professor in the Department of Clinical Pharmacy at the University of Colorado at Denver, and colleagues found that the annual rates of diagnosed episodes of depression had been increasing steadily from 1999 to 2004, but dropped precipitously in 2005. If the increasing trend had continued, they predicted that the rate of depression diagnosis in 2005 would have been about 40 percent higher than the actual rate of diagnosis, a statistically significant difference.

Compared with the trend in the five years before the first FDA advisory, the number of new episodes of diagnosed depression dropped significantly faster in the two years after the advisory, accounting for a lower percentage of all depression episodes. In this study, new episodes of depression were defined as a diagnostic claim of depression for someone who had not had a depression diagnosis in the prior four months or any antidepressant prescription claims in the prior three months.

The authors examined the practice type of physicians who diagnosed depression. Before the advisory, nearly half of the depressive episodes were diagnosed by primary care physicians, and this share was growing at an annual rate of 5.4 percent. After the advisory, the absolute proportion of depressive episodes diagnosed by primary care physicians was more than half of all diagnosed episodes, but the trend was in fact reversed, declining at an annual rate of 2.86 percent, a statistically significant change. Thus, the FDA warning may have made primary care physicians more reluctant to diagnose depressive episodes.

The pattern of depression diagnosis among psychiatrists and mental health professionals did not significantly change after the advisory.

The authors also analyzed antidepressant prescription claims that were filled within 30 days of each diagnosed depression episode. In the five years before the FDA advisory in October 2003, an average of 53 percent of depressive episodes were accompanied by pharmacy claims for selective serotonin reuptake inhibitors (SSRIs), with a slightly growing trend over time. The percentage of episodes in which an SSRI prescription was filled declined sharply after the advisory, with an annualized decreasing rate of 13.15 percent. By September 2005, less than a quarter of all depressive episodes were accompanied by a filled prescription for an SSRI.

Tricyclic antidepressant prescriptions saw a milder decline. No other antidepressants saw significant increases. The percentage of depressive episodes with no accompanying antidepressant prescriptions filled grew at an annualized rate of 20.62 percent between October 2003 and September 2005.

The increasing number of patients not receiving antidepressant drug therapy did not appear to be getting other treatment, either. The researchers found no statistically significant change in the percentage of depressive episodes that were followed by at least one psychotherapy visit within 180 days. Similarly, no change was seen after the advisory in atypical antipsychotic or anxiolytic prescriptions within 30 days after depression diagnosis.

“The most alarming element in our findings was that rates of diagnosis of depression went down after the warnings came out,” said Valuck. “It was not unexpected that rates of antidepressant prescribing would go down and that there could be compensatory increases in the use of other psychotropic medications and/or psychotherapy (although we didn't see any). But it was not expected that diagnosis rates would fall.”

Similar decreasing trends in the diagnosis and treatment of depression in children and adolescents were detected in a study using the same managed-care-claims database and published in the June American Journal of Psychiatry (Psychiatric News, June 15).

The study “Spillover Effects on Treatment of Adult Depression in Primary Care After FDA Advisory on Risk of Pediatric Suicidality With SSRIs” is posted at<ajp.psychiatryonline.org/cgi/content/full/164/8/1198>.▪