WASHINGTON Rep. Mike Ferguson, R-N.J., is criticizing the Food and Drug Administration, for its revised antidepressant medication guides because the warnings for children take the medications have been weakened compared to the old guide.
Ferguson said the guides include more generalized information regarding the risks for children, teenagers and young adults taking antidepressants. He also stated that the new guides use a generic warning that combines all three age groups into one category and abbreviates safety information.
In October 2003, the FDA issued an advisory warning of the increased risk of suicide in pediatric patients taking selective serotonin reuptake inhibitors for depression. After reviewing more data from pediatric studies, the agency told antidepressant manufacturers to revise their product labeling to include the risk of suicide in children and adolescents.