Black Box Warnings Decreased Pediatric Antidepressant Use

As reported in the Psychiatric Times - Strangely, they seem worried more about the decline of prescriptions, even though there has been a dramatic increase in prescriptions over the past decade.

Pediatric antidepressant prescriptions decreased by about 10% following black box warnings ordered by the FDA on an increased suicidality risk for these medications, researchers said here.

That decrease, which appeared to be mainly due to fewer new prescriptions, took place in the year after the warnings, according to the study reported at the American Academy of Child and Adolescent Psychiatry meeting.

"While not intended to discourage appropriate prescribing, concerns have arisen that the warning would result in hesitance to use potentially effective treatments," said Christine Thomason, Ph.D., of i3 Research in Basking Ridge, N.J., in a poster presentation.

The FDA found an increased risk for suicidal thoughts or behavior (average risk 4% versus 2% placebo) associated with some antidepressants, particularly SSRIs, and in October 2004 directed manufacturers to warn prescribers.

In the year after the warnings compared to the year before the warnings, the findings were:

* Overall prescriptions decreased by 9.7% (68,121 versus 61,561, P<0.0001).
* New prescriptions declined by 19.6% (54,902 versus 44,150, P<0.0001).
* SSRI or serotonin-norepinephrin reuptake inhibitor prescriptions in particular decreased by 11.9%.

The decreases may indicate less inappropriate prescribing of SSRIs with more "critical thinking" on the part of the prescribers, commented James McGough, M.D., of the University of California, Los Angeles.

"It seems certain that these medications are helpful in some circumstances, but I think prior to the warnings they were prescribed without much consideration of the potential risks of treatment," he added.

The investigators analyzed antidepressant claims data from a large U.S. health plan for patients ages 0 to 17 years. The average age of patients was 13.6. Most had a diagnosis of depressive disorder (30%) or attention deficit hyperactivity disorder (24%).

After the black box warning, the greatest decrease in use occurred in patients younger than nine. The researchers reported:

* A 17.8% drop in prescriptions to children younger than four.
* A 14.4% decrease in new prescriptions to children younger than four.
* A 14.6% overall decrease in prescriptions to children ages five to nine.
* A 13.8% decrease in new prescriptions to children ages five to nine.

However, the largest decline in first prescriptions occurred in the 15- to 17-year-old group (23.2% drop pre- versus post-warning).

Prescriptions for the SSRI Zoloft (sertraline) fell the most, along with those for the atypical antidepressant Wellbutrin (bupropion) and the SSRI Paxil (paroxetine). Prescriptions for the SSRI Prozac (fluoxetine) and the tricyclic Elavil (amitriptyline) rose.

Interestingly, the frequency of office visits increased from an average of 11.7 per year to 12.1 per year (P<0.0001). Patients with new prescriptions initiated after the warnings had an average of 13.0 visits per year.

This indicates increased awareness and monitoring of potential risks, said Dr. McGough.

Dr. Thomason said trends may have differed between general practitioners and child and adolescent psychiatrists but that these data could not be discerned.