Mirtazapine (marketed as Remeron)
Information
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 mirtazapine is prescribed for
children, FDA has not approved mirtazapine 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.
Other
Information
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Date created: May, 2005, updated May 2, 2007 |