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New Safety Warnings for Chantix

FDA alerts the public and health care providers to mood and behavior changes associated with this medicine to help people quit smoking

FDA issued a Public Health Advisory on Feb. 1, 2008, to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline). Chantix is a prescription medication used to help people stop smoking.

Chantix was approved by FDA in May 2006. In November 2007, FDA issued an Early Communication to tell the public and health care providers that the agency was evaluating adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal thoughts, and attempted and completed suicide.

As FDA continues its review of the adverse event reports, it appears increasingly likely that there may be an association between Chantix and serious mood and behavior symptoms.

FDA has requested that Pfizer, the manufacturer of Chantix, give the safety information a more prominent position on the drug's prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” says Bob Rappaport, M.D., Director of FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. "Patients should talk with their doctors about this new information and whether Chantix is the right drug for them."

Tips for Consumers

* Tell your health care provider about any history of psychiatric illness before you start taking Chantix.
* Immediately tell a doctor if you or someone you care for has any changes in mood and behavior while being treated with Chantix. In most cases, mood and behavior changes developed during treatment, but some people developed symptoms after they stopped taking Chantix.
* Be aware that vivid, unusual, or strange dreams may occur while taking Chantix.
* Chantix may affect your ability to drive or operate machinery.

Recommendations and Considerations for Healthcare Professionals

* Healthcare providers should monitor all patients taking Chantix for symptoms of serious neuropsychiatric symptoms. Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior. These symptoms have sometimes occurred in patients without pre-existing psychiatric illness and have worsened in some patients with pre-existing psychiatric illness treated with Chantix. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

* 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 Chantix. Patients with serious psychiatric illness did not participate in the pre-marketing studies of Chantix. The safety and efficacy of Chantix in these patients has not been established.

* While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert patients about these risks.

Information for the patient: Physicians who prescribe Chantix should discuss with their patients, patients’ families, and caregiver the following:

* Tell the doctor about any history of psychiatric illness prior to starting Chantix. Patients taking Chantix have experienced worsening of current psychiatric illness, even if it is currently under control, and the reoccurrence of previous psychiatric illness.
* Be alert to changes in mood and behavior. Symptoms include strange thoughts or behaviors, depressed mood, and thinking about or attempting suicide.
* Immediately report changes in mood and behavior to the doctor.
* Vivid, unusual, or strange dreams may occur while taking Chantix.

Background Information and Data

FDA first informed the public about the possibility of serious neuropsychiatric symptoms in the November 20, 2007 FDA Early Communication About an Ongoing Safety Review. At that time, information about serious neuropsychiatric symptoms in patients taking Chantix was added to the POST-MARKETING EXPERIENCE section of the prescribing information. As FDA’s review of the data has progressed and FDA has received additional information, it has become increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA requested that Pfizer, the manufacturer of Chantix, add the information to the WARNINGS and PRECAUTIONS sections of the Chantix prescribing information so that healthcare professionals and patients can be more alert to these issues [insert link to label]. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

FDA will update healthcare professionals about new information from FDA’s continuing review of the data or new information that it receives on Chantix and serious neuropsychiatric symptoms. FDA may consider additional regulatory action as the data review and conclusions warrant.


The information provided should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed physician should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies.

Copyright Information: Public domain information with acknowledgement given to the U.S. National Library of Medicine.

2 comments:

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