December 2004, Volume 34 Number 12 , p 30 - 30
© 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. ...