March 22,2004

FDA Advisory on Antidepressants in Adults and Children

M E M O R A N D U M

TO: Reporters and Editors
RE: FDA Advisory, Antidepressants in adults and children
DA: March 22, 2004

Sen. Chuck Grassley, Chairman of the Senate Committee on Finance, today commented on the public health advisory issued by the Food and Drug Administration (FDA) regarding antidepressants in adults and children.

In recent weeks, Sen. Grassley's investigative staff had gathered information about a report completed by FDA scientist Andrew Mosholder, which indicated possible increased risk of suicidal behavior among children being treated for depression with certain anti-depressants. Sen. Grassley made inquiries based on allegations that the FDA had resisted releasing these new findings about the effect of such drugs on children and adolescents, in particular. Sen. Grassley will continue to investigate whether or not the FDA attempted to suppress the information that was made public in today’s advisory.

“It would have been very wrong for the FDA to withhold any information it had aboutunintended consequences that might result from the use of anti-depressants, especially for childrenand adolescents. The public deserves to know of every possible risk so that family members canclosely monitor any changes in behavior.”