DRUG NEWS: Antidepressants get black-box warning

December 2004 
Volume 34  Number 12
Pages 30 - 30
  PDF Version Available!

© 2004 Lippincott Williams & Wilkins, Inc. Volume 34(12)             December 2004             p 30 Antidepressants get black-box warning [DRUG NEWS: PEDIATRIC SUICIDE RISK]

Because of a link between antidepressant use and suicidal thoughts and behavior in some children and teenagers, all antidepressants now carry a “black-box” safety alert. Fluoxetine (Prozac) is currently the only antidepressant approved by the FDA for treating depression in children, although several others are approved for treating obsessive-compulsive disorder in children. However, health care providers can (and do) prescribe antidepressants off-label for pediatric patients.

The black-box warning, established in October, results from mounting evidence that antidepressants can trigger suicidal thoughts and behavior in a small proportion (about 3%) of pediatric patients during the first few months of treatment. ...

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