National Alliance on Mental Illness
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FDA Issues Advisory on Antidepressants
NAMI applauds the FDA for issuing a public health advisory on March 22, 2004 that calls for the careful monitoring of children and adults using antidepressant medications. We believe that sound clinical practice calls for providers serving people living with mental illnesses to always closely monitor and evaluate their patients to address any changes in their symptoms.
The FDA advisory comes in the midst of its review of antidepressant use in children. The advisory states that "it is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior."
The advisory contains two recommendations – first, that adults and children prescribed antidepressant medications should be closely monitored for worsening depression, suicidal thinking, and certain other behaviors when first prescribed these medications or following changes in dosages. Second, the FDA is asking manufacturers of antidepressant medications to include stronger cautions and warnings about the need to monitor patients for worsening depression and suicidal ideation.
NAMI commends the FDA for its efforts to educate physicians, other mental health providers, consumers and families about the importance of such monitoring. This recommendation is consistent with the testimony provided by Suzanne Vogel Scibilia, M.D., a psychiatrist and member of NAMI’s Board of Directors, at an FDA hearing on antidepressants and children on February 2, 2004. Click here to read a copy of Dr. Vogel Scibilia’s testimony.
Antidepressants have been lifesaving for some youth and adults living with major depression that use the medication to help control the often severe symptoms of their illnesses. For this reason, NAMI is concerned that the FDA Public Health Advisory should not discourage providers from prescribing these medications when clinically indicated.
NAMI will monitor further developments related to antidepressant medication use in children and adults and will report additional information as it becomes available.
More information about the FDA’s advisory can be found at http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01283.html.