FDA ALERT [7/2005] – Suicidal Thoughts or Actions in
Children and Adults
Patients
with depression or other mental illnesses often think about or
attempt suicide. Closely watch anyone taking antidepressants,
especially early in treatment or when the dose is changed.
Patients who become irritable or anxious, or have new or
increased thoughts of suicide or other changes in mood or
behavior (or their care givers) should contact their healthcare
professional right away.
Children
Taking antidepressants may increase
suicidal thoughts and actions in about 1 out of 50 people 18
years or younger. Although nefazodone is prescribed for
children, FDA has not approved nefazodone for use in children.
Adults
Several recent scientific
publications report the possibility of an increased risk for
suicidal behavior in adults who are being treated with
antidepressant medications. Even before these reports became
available, FDA began a complete review of all available data to
determine whether there is an increased risk of suicidal
thinking or behavior in adults being treated with
antidepressant medications. It is expected that this review
will take a year or longer to complete. In the meantime, FDA is
highlighting that adults being treated with antidepressant
medication, particularly those being treated for depression,
should be watched closely for worsening of depression and for
increased suicidal thinking or behavior.
This information reflects FDA’s preliminary analysis of data
concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information. FDA intends to update this
sheet when additional information or analyses become available.