Mental Health Problems Linked To Chantix, Zyban
The FDA notified the public that the use of two prescription medicines used to help smoking cessation, Chantix (varenicline) manufactured by Pfizer Inc or Zyban(bupropionhydrochloride) manufactured by GlaxoSmithKline, has been associated with reports of behavior changes including hostility, agitation, depressed mood, and suicidal thoughts or actions. The FDA is requiring the manufacturers of these products, including generic versions of Zyban (bupropion), to add a new Boxed Warning to the product labeling to alert healthcare professionals to this important new safety information. The new precautions being recommended include:
People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away.
Friends or family members who notice these changes in behavior in someone who is taking Chantix or Zyban for smoking cessation should tell the person their concerns and recommend that he or she stop taking the drug and call a healthcare professional right away.
Dr. Janet Woodcock, director, the FDA’s Center for Drug Evaluation and Research, said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes. “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Woodcock, “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”
Similar information on mental health events will be required forbupropion marketed as the antidepressant Wellbutrin and for generic versions of bupropion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.
These additional warnings are based on a review of reports submitted to the agency’s Adverse Event Reporting System. They revealed that some individuals who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped. Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking.
Manufacturers will also be required to conduct a clinical trial to determine how often serious neuropsychiatric symptoms occur in patients using various smoking cessation therapies, including patients who currently have psychiatric disorders. The FDA’s review of adverse events for patients using nicotine patches did not identify a clear link between those medications and suicidal events.
This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA is not advising practitioners to discontinue prescribing these products. FDA intends to update the information when additional information or analyses become available. To report any unexpected adverse or serious events associated with the use of these drugs, please contact the FDA MedWatch program using the information at the bottom of the page.
The FDA issued the following recommendations and considerations for healthcare professionals.
* It is important to discuss the possibility of serious neuropsychiatric symptoms in the context of the benefits of quitting smoking with patients before prescribing these medications. Varenicline and bupropion are both effective smoking cessation aids and the health benefits of smoking cessation are immediate and substantial.
* Healthcare professional should monitor all patients’ takingvarenicline and bupropion for serious neuropsychiatric symptoms. These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal ideation, suicidal behavior and attempted suicide. These symptoms have occurred in patients without pre-existing psychiatric illness and have worsened in some patients with pre-existing psychiatric illness. In most cases, neuropsychiatric symptoms developed during treatment with varenicline or bupropion but in others, symptoms developed after stopping drug treatment.
* Patients should be informed that it is not unusual to have symptoms such as irritability, feeling anxious, depressed mood and trouble sleeping when they are withdrawing from nicotine, independent of whether they are taking vareniclineor bupropion.
* Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder, may experience worsening of their pre-existing psychiatric illness while taking varenicline or bupropion.
Patients who discontinue treatment because of neuropsychiatric events should continue to be monitored until symptoms resolve. Although symptoms resolved after treatment was stopped in many cases, there were also some cases where the symptoms persisted.
Additional information for healthcare professionals to discuss with patients, family members, and caregivers include:
* Quitting smoking can decrease the chances of lung and heart disease and getting cancer. These important health benefits should be weighed against the small, but real, risk of serious adverse events with use of varenicline or bupropion.
* Worsening or recurrence of psychiatric illness. Patients should be told that some patients taking varenicline or bupropion have experienced worsening of their psychiatric illness, even when the illness was under control and some patients have experienced a recurrence of a previous psychiatric illness when taking these drugs for smoking cessation.
* Unusual changes in mood and behavior. Patients should be instructed to contact their healthcare provider immediately if they observe or develop thoughts about suicide or attempting suicide, feel agitated, aggressive or violent and other unusual changes in mood or behavior.
* Some symptoms are to be expected when quitting smoking. Patients should be told that it is not unusual to have symptoms such as irritability, feeling anxious, depressed mood and trouble sleeping when they are withdrawing from nicotine, independent of whether they are taking varenicline or bupropion and that vivid, unusual, or strange dreams may occur while taking Chantix and are not a cause for alarm.
* Discuss other methods of quitting smoking if it is decided thatvarenicline or bupropion are not the best treatment option.