The anti-smoking drug Chantix® was initially linked to depression, suicidal thoughts, and violent behavior in some users, according to the Food and Drug Administration (FDA) (1, 2). In July of 2011, a study found that Chantix use may increase the risk of heart attacks and strokes by as much as 72 percent in smokers who take it, even those without heart disease.
Chantix comes in a white tablet (0.5mg) and a blue tablet (1mg) and is usually taken for 12 weeks at a time.
Chantix Linked to Psychiatric Problems, Black Box Warning Added:
From the FDA: “The FDA is notifying the public that the use of Chantix(varenicline) or Zyban (bupropion hydrochloride), two prescription medicines that are used as part of smoking cessation programs, has been associated with reports of changes in behavior such as 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 Box Warning to the product labeling to alert healthcare professionals to this important new safety information.
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.”
According to Reuters, the Federal Aviation Administration (FAA) has prohibited its pilots from using Chantix because of its possible dangers, which also include blurred vision, dizziness, confusion, loss of consciousness, and a previously established link to suicidal behavior.
In February 2008, the FDA Issued the Following Statement:
FDA is issuing this Alert to highlight important revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms. Serious neuropsychiatric symptoms have occurred in patients taking Chantix.
These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking.
In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.
In September 2009, the FDA Issued the Following Statement:
The FDA’s analysis of adverse event reports shows that when neuropsychiatric symptoms occur, they usually develop during drug treatment, but symptoms can also develop after the drug is stopped.
Some patients on these drugs who had no history of psychiatric illness experienced suicidal ideation and behavior for the first time. The drugs have also been associated with a worsening of symptoms in patients with pre-existing psychiatric disorders (4).
July 2011 Update:
The results of a major study published in the Canadian Medical Association Journal found that Chantix may increase the risk of heart attacks and strokes by as much as 72 percent in smokers who use the drug. The authors of the study noted the potential risks outweigh the benefits, and recommended users find safer, cheaper alternatives.
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Chantix® is a registered trademark of Pfizer Inc. and is used here only to identify the product in question.
This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration or Pfizer Inc.