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Tuesday, January 8, 2008

FDA Warning doesn't put Youth at Increased Risk

Paroxetine warnings by the FDA in June 2003 resulted in a significant absolute decline in paroxetine use by adolescents but not in the use of other antidepressants by young people. The FDA black box warning for paroxetine in October 2004 resulted in a nonsignificant decline in antidepressant treatment of adolescents, including a significant deceleration in the rate of treatment with SSRIs other than paroxetine.

This outcome of a recent study published in the Archives of General Psychiatry of January 2008 neutralizes the concern expressed mostly by drug company supported publications about putting depressed youth at risk due to excessive decline in antidepressant prescribing.

These results are consistent with other studies in Ireland and Canada who also found little change in SSRI prescriptions to youth between during the last years.

In the United States, the first indication of a possible increased risk of suicidal thoughts and behaviors associated with antidepressant treatment occurred on June 19, 2003, when the FDA announced that it was reviewing "a possible increased rate" of suicidal behavior in youth treated with paroxetine hydrochloride.

The FDA recommended that paroxetine not be used in children and adolescents for the treatment of major depressive disorder. Additional warnings from the FDA and other international drug regulatory agencies followed over the next several months. On October 15, 2004, the FDA issued a boxed warning or so-called black box warning that all antidepressants pose significant risks of suicidality in children and adolescents and that children and adults treated with antidepressants should be watched closely for increased suicidal thinking or behavior.

This warning received extensive media attention and academic interest. It is the strongest action that the FDA can take short of withdrawing drug approval.

Other findings:
The rate of new use by youth of paroxetine declined significantly after the paroxetine warning of 2003 and was nearly constant after the black box warning.

In adults (18-64) the use of all antidepressants was constant after the paroxetine warning but the use of paroxetine declined and the use of other antidepressants significantly increased.

For adults 65 years and older overall antidepressant use significantly increased.
Changes in the pattern of antidepressant use varies little by patient sex.

Different events such as media coverage and warnings in other countries such as the UK might also have influenced prescriptions not covered by this study.

The effect of warnings on different disorders could not be assessed.

The effect of warnings by the FDA on other treatments such as psychotherapy was not assessed in this study.

The specialty of the prescribing physician was not available for about 20% of the patients.

The analyses are limited to members of 1 pharmacy benefit manager. Data were extracted from the Medco data warehouse. Medco is one of the largest pharmacy benefit management services in the United States.

Related posts on this blog:
SSRI prescription drop associated with suicide increase in children
7 Posts about adolescents and depression

Article Discussed:
Effects of Food and Drug Administration Warnings on Antidepressant Use in a National Sample
Mark Olfson, MD, MPH; Steven C. Marcus, PhD; Benjamin G. Druss, MD, MPH
Arch Gen Psychiatry. 2008;65(1):94-101.
Blogging on Peer-Reviewed Research

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