Safety Alerts & Recalls
What does this mean?
Regardless of the reason you are taking Bupropion, unexplained mood and behavior changes may occur when taking this medication, especially in the first few weeks of beginning treatment and when your dose changes. This alert is a reminder to report any unusual changes in your mood or behavior to your doctor.
If you are taking Bupropion to help you quit smoking, this alert highlights the importance of weighing the possible risks of serious adverse events occurring while using Bupropion against the significant health benefits of quitting smoking. The health benefits of quitting smoking include a reduction in the chance of developing lung disease, heart disease, or cancer.
It is not unusual to have symptoms such as irritability, feeling anxious, depressed mood and trouble sleeping when you are withdrawing from nicotine, whether you are taking smoking cessation drugs like Bupropion or not. With that said, if you are taking Bupropion you should be aware that Bupropion may cause changes in mood and behavior and contact your health care provider immediately if you experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if you experience suicidal thoughts or behavior. You may also wish to alert your family members, friends, or caregivers about the potential for changes in mood or behavior with Bupropion and instruct them to contact your health care provider if they observe these changes in you.
If you would like to know more about the risks and benefits of Bupropion, please talk to your doctor about your concerns.
New Boxed Warning For Bupropion (marketed as Zyban, Wellbutrin, and generics)
The FDA announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the drugs used for smoking cessation, including bupropion (marketed as Zyban, Wellbutrin, and generics) and varenicline (marketed as Chantix). Bupropion currently has a Boxed Warning relating to an increased risk of suicidal thoughts and behavior when used in children and adolescents with depression. The new warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts and behavior when taking these drugs for smoking cessation. The FDA is also requiring the manufacturers of bupropion to update the Medication Guide to highlight these risks.
Bupropion is approved for use in the treatment of depression, seasonal affect disorder, and as an aid to smoking cessation treatment.
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