Revisions to Antidepressant Product Labels

The manufacturers of antidepressants, in consultation with the Food and Drug Administration, have revised the labeling for their products to include a boxed warning regarding the increased risk of suicidality in children and adolescents. Significant revisions have also been made to the WARNINGS and PRECAUTIONS sections of the labeling for all antidepressants regardless of class.

For more information about these changes, refer to the FDA web site on antidepressant use in children, adolescents, and adults, www.fda.gov/cder/drug/antidepressants/default.htm. There you will find a Label Template PDF that details out the revisions, www.fda.gov/cder/drug/antidepressants/PI_template.pdf. A PDF of the Medication Guide is also available on the site, www.fda.gov/cder/drug/antidepressants/MG_template.pdf.