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CDC CAUTIONS AGAINST LINKING BLACK BOX WARNINGS TO RISE IN SUICIDES

February 14, 2007

While recent Centers for Disease Control and Prevention (CDC) data show an increase in the number of adolescent suicides since black box warnings were added to some types of antidepressants, there may not be enough data to link the two, a government source says.

An assessment by the CDC's National Center for Health Statistics (NCHS) shows that the suicide rate among teenagers rose between 2003 and 2004, leading such activist groups as Mental Health America to question whether the FDA played a role in the increase.

However, while the suicide increase coincides with the FDA's decision to require black box warnings on SSRIs, this does not necessarily mean that the warnings led to more suicides Arialdi Miniño, a NCHS statistician, said.

The fact that the rates were even higher between 1999 and 2001 lends doubt to the theory that black box warnings are the cause, he said. The data would be more significant if the rates were flat before the black boxes, he added.

But Mental Health America wants the agency to address that issue, alleging that these warnings led to decreased use of the drugs. "While drawing conclusions related to the causes of this increase would be premature, it could be related to actions of the Food and Drug Administration," David Shern, the group's CEO said. "We must therefore wonder if the FDA's actions and the subsequent decrease in access to these antidepressants in fact have caused an increase in youth suicide," Shern added. The group is calling on the federal government to "move aggressively" to determine if the warnings are, in part, responsible for the increase in suicides.