Patient group criticizes black box warning

May 14, 2007

The FDA's plan to extend the current black box warning on antidepressants has met with opposition from the Depression and Bipolar Support Alliance (DBSA), a patient-run organization. The group charges that adding a warning of the risk of suicidal thinking and behavior in young people between the ages of 18 and 24 years could lead to higher numbers of untreated patients and potential for an increased risk of suicide.

Patient group criticizes black box warningThe FDA's plan to extend the current black box warning on antidepressants has met with opposition from the Depression and Bipolar Support Alliance (DBSA), a patient-run organization. The group charges that adding a warning of the risk of suicidal thinking and behavior in young people between the ages of 18 and 24 years could lead to higher numbers of untreated patients and potential for an increased risk of suicide. DBSA president Sue Bergeson cited the 2004 addition of the black box warning as an example, with a 13% decrease in the use of antidepressants among children and teens following the change in labeling, followed by a double-digit rise in suicide rates in the same age group. "People became overly concerned about the risks of antidepressants and, as a result, went untreated. Lives may very well have been lost as a consequence of good intentions on the part of the FDA," she said.

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