Chantix® is used as a smoking cessation medicine or treatment. In 2009, the FDA required that the manufacturers of the smoking cessation drugs varenicline (Chantix) and bupropion (Zyban and generics) add new boxed warnings and develop medication guides for patients that highlight the risk of serious neuropsychiatric symptoms in patients using these products.
January 2008 - Pfizer announced that it is strengthening the U.S. warnings on its smoking cessation drug Chantix (varenicline). The updated label warnings ask doctors to monitor their patients for incidences of depressed mood, agitation, suicidal thinking and suicidal behavior, which have been reported among some Chantix users. Until now, this information had been in a less prominent section of the instructions.
The updated warnings follow the FDA's announcement in November 2007 that it is conducting an Ongoing Safety Review of Pfizer's Chantix amid post-marketing reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken the drug. The FDA is reviewing these cases, along with other reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of beginning Chantix treatment.
Chantix is a prescription drug approved by the FDA in May 2006 to help adult cigarette smokers stop smoking. Chantix does not contain nicotine. It works by stimulating nicotine receptors in the brain, just as nicotine does, but blocks the nicotine from attaching to them, reducing the pleasurable effects of tobacco as well as the desire to smoke.
Common side effects associated with Chantix use include nausea, depression, anxiety, heart palpitations and vivid dreams. It has also been linked to more serious side effects such as erratic and violent behavior, psychotic episodes and suicidal thoughts.
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