Anti-Smoking drug Chantix linked to suicidal thoughts, violent behavior and psychotic episodes.
Chantix, known generically as varenicline, is a smoking cessation drug manufactured by Pfizer. Pfizer recently announced that it is strengthening the U.S. warnings on its smoking cessation drug Chantix. 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 warnings come as a result of the Food and Drug Administration (FDA) 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. The FDA noted that there are reports of association between the drug and suicide or attempted suicide “within days to weeks of initiating Chantix treatment”.
How Chantix Works
Chantix is a prescription drug that was approved by the FDA in May 2006 to help adult cigarette smokers stop smoking. Chantix does not contain nicotine. It was marketed to help stop smoking 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. Simply put, Chantix works as an “antagonist” to reducing the psychological reward associated with smoking.
Chantix Side Effects
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.
Pfizer knew or should have known that its drug increased the risk of causing suicide or attempted suicide and similar adverse events. As early as 1972, one of its ingredients cylosine, was documented as being linked to such. Despite this known link, Pfizer failed to study the drug to determine the risks of these adverse events. In fact, for the clinical trials, Pfizer excluded patients for the study, if they had a previous history or diagnosis of mental/psychological disorders. In fact, Pfizer now acknowledges that patients with such diagnosis disorders such as schizophrenia, bipolar disorder and major depression disorder did not participate in their enrolled study.
If you or someone your know has taken Chantix and suffered any serious side effects, please r call us at 1-800-451-6393 for a discussion regarding your rights and information about compensation for injuries. In fact, friends of the firm have reported mood swings after just starting this medication.