SMOKING DRUG CHANTIX®LINKED TO SUICIDAL BEHAVIOR AND DEPRESSION
The anti-smoking drug Chantix® was initially associated with depression, suicidal thoughts, and violent actions in some users, according to the Food and Drug Administration (FDA) (1, 2). In July of 2011, a study found that the using the anti-smoking drug Chantix can increase the risk of strokes and heart attacks by as much as 72 percent of all smokers who take it, in some cases it even effects those without a history of heart disease.
Chantix comes in a white tablet (0.5mg) and a blue tablet (1mg) and is generally taken in 12 week cycles.
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, some of the problems linked to Chantix are agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some cases patients have experienced these types of symptoms and events because of nicotine withdrawal, some patients using Chantix who experienced serious neuropsychiatric symptoms and events had not yet been able to discontinue smoking.
In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed on after 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 throughout drug treatment, but symptoms can also develop after the drug has stopped being taken by the patient.
Some patients on these drugs who previously had no history of psychiatric illness experienced symptoms such as, suicidal ideation and behavior for the first time. The drugs have also been associated with a increase risk 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 can 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 highly recommend users find safer, less expensive alternatives.
Black Box Warning Added, Psychiatric Problems linked to the use of Chantix:
From the FDA: “The FDA is notifying the public that the use of Zyban (bupropion hydrochloride, or Chantix (varenicline), two prescription medicines that are prescribed as part of smoking cessation programs, has been associated with reports of changes in behavior such as depressed mood, agitation, hostility, and suicidal thoughts or actions.
As a result the FDA is requiring the manufacturers of these products to place a new Box Warning to the product labeling, in order to alert healthcare professionals and those currently prescribed these medications, to this important new safety information, including generic versions of Zyban (bupropion).
People who are taking Zyban or Chantix who are also experiencing any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop using the medicine immediately 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 their prescribing doctor right away.”
According to Reuters, the Federal Aviation Administration (FAA) has prohibited its pilots from using Chantix because of its possible dangers, which can also include blurred vision, dizziness, confusion, loss of consciousness, and an established link to suicidal behavior.
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Chantix® is a registered trademark of Pfizer Inc. and is used here only to identify the product in question.
Sources:
- “Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix).” FDA. Accessed 11/30/07.
- “FDA Public Health Advisory from the FDA.” Accessed 7/6/09.
- “Warning on Neuropsychiatric Effects from Smoking Cessation Drugs from the FDA.” FDA. Accessed 9/2/2009.
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