The controversy over these pills keeps growing. Now, the FDA is proposing that every manufacturer update the existing Black Box warning on the products labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally, the first one to two months).

The proposed labeling changes also include language stating that scientific data didn’t show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warnings also emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

The move comes just two weeks after a controversial meta-analysis in the Journal of the American Medical Association suggested that the benefits of antidepressants for children and teens far outweigh the risk of suicide, and the FDA should revise strong warnings that may have scared off some doctors and patients.

The latest update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At the time, the FDA asked drugmakers to add a Black Box warning to the labeling to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these meds.

The agency also directed manufacturers to develop and distribute Medication Guides, although that effort has fallen short and the FDA is holding a meeting next month to find out what went wrong and how to fix the problem.

Last December, the FDA’s Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants.

In a statement, the American Psychiatric Association “welcomed” the label change, saying that the “new labeling acknowledges, for the first time, that untreated depression puts people at risk for suicide.” The professional group has been ranting against the Black Box warning over concerns patients who need antidepressants may not receive treatment.

Here’s the FDA statement;
The recent JAMA study (subscription may be required).[tags]Antidepressants, Drug Safety, FDA[/tags]