Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised
AUDIENCE: Internal Medicine, Pharmacy, Psychiatry
ISSUE: Based on an FDA review of a large clinical trial that FDA required the drug companies to conduct, FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past. However, most people who had these side effects did not have serious consequences such as hospitalization. The results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines. See the Drug Safety Communication for a data summary.
As a result of the large clinical trial review, FDA is removing the Boxed Warning, FDA's most prominent warning, for serious mental health side effects from the Chantix drug label. The language describing the serious mental health side effects seen in patients quitting smoking will also be removed from the Boxed Warning in the Zyban label. FDA is also updating the existing warning section in both labels that describes the side effects on mood, behavior, or thinking to include the results from the clinical trial. This decision is consistent with the recommendations of external experts at a September 2016 FDA Advisory Committee meeting. The patient Medication Guide that explains the risks associated with the use of the medicines will continue to be provided with every patient prescription; however, the risk evaluation and mitigation strategy (REMS) that formally required the Medication Guide will be removed.
BACKGROUND: FDA review of the clinical trial results also confirmed that Chantix, Zyban, and nicotine replacement patches were all more effective for helping people quit smoking than was an inactive treatment called a placebo. These medicines were found to better help people quit smoking regardless of whether or not they had a history of mental illness.
RECOMMENDATION: Health care professionals should counsel patients about the benefits of stopping smoking and how they can get help to quit, and discuss the benefits and risks of using medicines to help them quit smoking.
Patients should stop taking Chantix or Zyban and call their health care professionals right away if they notice any side effects on mood, behavior, or thinking. Patients should also talk to their health care professionals for help and information about stopping smoking, including about whether stop-smoking medicines may help or if they have any questions or concerns about taking a medicine (See Related Information for more quit smoking resources).
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533517.htm
根據美國FDA回顧一大型的臨床試驗，結果顯示varenicline及bupropion此兩種戒菸藥品發生心情、行為或思想上副作用之風險低於預期；然而此副作用仍有發生之風險，尤其是對於目前正在治療心理疾病（例如：憂鬱症、焦慮症或思覺失調症）者，或是曾有心理疾病病史者，但大部份的病人並未因副作用而導致嚴重後果（例如：住院）。另外在療效方面，Varenicline、bupropion及尼古丁替代療法之貼片相較於安慰劑，對於戒菸更有效。根據此試驗結果證實使用藥品戒菸之益處大於其可能產生副作用之風險。
因此美國FDA修訂varenicline及bupropion仿單，根據試驗結果更新關於心情、行為或思想上之副作用。醫療專業人員應教育病人戒菸的好處及使用戒菸藥品相關的效益與風險，病人若在服用藥品上有任何問題或考量，皆應與醫療專業人員溝通和詢問。美國FDA也提醒病人若服用藥品時出現任何關於心理、行為或是思想上之副作用，應立即停用varenicline或bupropion，並通知相關醫療專業人員。
[Posted 12/16/2016]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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