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FDA Public Health Advisory, March 22, 2004
Worsening Depression and Suicidality in Patients Being Treated With Antidepressants
http://www.fda.gov/cder/drug/antidepressants/AntidepressanstPHA.htm  

FDA Public Health Advisory, June, 2005 http://www.fda.gov/cder/drug/advisory/SSRI200507.htm

 

FDA Public Health Advisory Dec. 13, 2006
FDA Will Likely Expand Antidepressant Drug Warnings;

The Food and Drug Administration (FDA) will likely expand antidepressant drug warnings after members of a U.S. advisory panel agreed with an FDA analysis that found antidepressant use raises the risk of suicidal thoughts and behavior in teens and young adults up to age 24. http://psychcentral.com/news/2006/12/13/fda-will-likely-expand-antidepressant-drug-warnings/

 

FDA Public Health Update May 2, 2007 (two weeks after VA Tech murders)
Antidepressant Use in Children, Adolescents, and Adults.
The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their 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). http://www.fda.gov/cder/drug/antidepressants/default.htm 

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• Health care providers should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases. Although FDA has not concluded that these drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

• Heath care providers should carefully evaluate patients in whom depression persistently worsens, or emergent suicidality is severe, abrupt in onset, or was not part of the presenting symptoms, to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated.

• Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric. Although FDA has not concluded that these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Therefore, therapy should be evaluated, and medications may need to be discontinued, when symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

• If a decision is made to discontinue treatment, certain of these medications should be tapered rather than stopped abruptly (see labeling for individual drug products for details).

• Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

• Health care providers should instruct patients, their families and their caregivers to be alert for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.