New Safety Warnings for Chantix
By MedHeadlines • Feb 3rd, 2008 • Category: Drugs, Editor's Picks, FDA, Smoking Cessation
The U.S. Food and Drug Administration (FDA) has requested Pfizer to change its safety and precautions information regarding the use of Chantix (varenicline). The agency has evaluated reports on adverse effects of the drug since November 20, 2007. It now appears that there may be an association between Chantix and neuropsychiatric changes, such as agitation, depressed mood and suicidal behavior.
“Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” said Bob Rappaport, M.D., director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. “While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug.”
Chantix was first approved in May of 2006, as a smoking cessation drug acting on parts of the brain affected by nicotine.
I took chantix for a few weeks, but quit because the side effects scared me. I have always been a positive and generally happy person, but once on the medication I felt completely different. I cried for no reason, experienced bouts of giddiness and found myself thinking what could best be described as “dark thoughts,” for lack of a better explanation. One example: I suddenly realized I was pushing a tack into my palm, but hadn’t been aware I was doing it. I felt emotions like suspicion, anger and even hatred in a manner not typical with my personality. This all occurred in the first few weeks, and I had not quit smoking (though I did cut down significantly). Considering myself an emotionally stable person who is happy with her life (well, except for the smoking part), I agree that there should be concern about this drug - especially for use by people who have any mental instability whatsoever.
I’ve used it, it helped me cut down considerably, I mean going without a cigarette for days and not even thinking about them but the biggest thing that I’ve noticed were strange dreams and hard time sleeping in general