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.
Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. Although bupropion is prescribed for children, FDA has not approved bupropion for use in children.
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.
Patient Information Sheet
Bupropion hydrochloride (marketed as the antidepressant Wellbutrin)
5/2007: The suicidal thoughts or actions in children and adults
issue has been addressed in product labeling.
Please see: http://www.fda.gov/cder/drug/antidepressants/default.htm
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570
• Other side effects include agitation, dry mouth, trouble sleeping, headache and migraine, nausea and vomiting, constipation, and tremor
• Tell your healthcare professional about all your medical conditions, especially if you have liver, kidney, or heart disease. Tell your healthcare professional if you are pregnant or plan to become pregnant. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby.
Are There Any Interactions With Medicines Or Foods?
• Bupropion may interact with medicines other than the ones already mentioned in this information sheet, causing serious side effects. Tell your healthcare professional about all the medicines, vitamins, and herbal supplements you take, especially those used for treating seizures, depression, mental illness, asthma, high blood pressure, or heart problems.
• If you plan to drink alcohol, talk to your healthcare professional.
How Do I Take Bupropion?
• Bupropion is taken by mouth, with or without food, exactly as prescribed by your doctor.
• Swallow tablets whole. Do not chew, crush, or divide bupropion tablets.
Is There Anything Else I Need to Know?
You can get more information about antidepressants at: http://www.fda.gov/cder/drug/antidepressants/default.htm
Wellbutrin FDA Approved 1985
Patient Information Sheet Revised 02/2005
Patient Information Sheet Revised 07/2005