Wellbutrin FDA Alert
FDA ALERT [05/2005]– Suicidal Thoughts or Actions in Children
Patients with depression or other mental illnesses often think about or attempt suicide.
Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50
people 18 years or younger. 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 should
be evaluated by their healthcare professional right away. Although Wellbutrin is prescribed
for children, it has not been approved by FDA for use in children.
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.
FDA Alert [05/2005]: Suicidality in Pediatric Patients
FDA has concluded that suicidal thinking or behavior may increase in pediatric
patients treated with antidepressants, especially early in treatment. Increases
in suicidal thinking or behavior due to drug can be expected in about 1 out of
50 treated pediatric patients. All patients being treated with antidepressants
should be observed closely for clinical worsening and suicidality especially
during the first few months of therapy and when the dose is modified. Note that,
although Wellbutrin is prescribed for pediatric patients, it has not been approved by FDA for use in pediatric patients.
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.
Wellbutrin Names
Bupropion is marketed under these names:
Wellbutrin
Wellbutrin SR
Wellbutrin XL
Zyban
buproprion hydorchloride