FDA Reviewing Safety of Chantix
The U.S. Food and Drug Administration (FDA) has issued a notice that it is conducting a safety review of the stop-smoking drug Chantix (varenicline) due to reports of suicidal thoughts and aggressive and erratic behavior in patients who were taking it.
In conducting its review, the FDA will be looking at postmarketing cases submitted by the drug's manufacturer, Pfizer, as well as reports in the press and on internet sites.
The investigation into Chantix's safety was first triggered by the death of a musician named Carter Albrecht, who played keyboards for singer Edie Brickell. While he was taking Chantix, he began banging on the door of his neighbor’s house, yelling and ranting. The neighbor responded by shooting and killing him. While Albrecht's girlfriend has publicly blamed Chantix, he was also drinking around the time of his erratic behavior and it is unclear what role that may have played.
Preliminary assessment of the reports indicates that many patients developed symptoms of depression and suicidal ideation within days or weeks of starting the medication. In addition, not all patients had pre-existing mental illness or were experiencing nicotine withdrawal, both of which could have potentially explained their symptoms had they existed.
While the investigation continues, the FDA is advising health care providers to monitor their patients for any changes in behavior or mood and advises that patients should communicate with their doctors if they experience any changes as well.
The full text of the Early Communication about the Ongoing Safety Review can be found at: http://www.fda.gov/cder/drug/early_comm/varenicline.htm.
Comments
i was perscribed chantix to quit smoking around march 2007 i think at a walk in facility. within weeks i became drepressed. i didnt understand why.. i even said to my husband ” i think im depressed!” after that i began to have suicidal thoughts. scared the crap out of me. I am very away of myself and as soon as i had those thoughts i stopped takeing chantix. At a different walk in facility i asked the dr there if it could cause depression.. although he said no..he said it was good that i stopped taking it.
I did remain depressed although no thoughts of suicide.. i have been seeking help for depression since July or Aug. 2007.
Ive been taking Chantix for two and a half months.The only side effect Ive had is gas..This is the first time I have be able to stop smoking for any lengh of time. Chantix has been a life saver for me. I have been smoke free for fifty one days. It is so good just to be able to take a deep breath and not cough. I thank God for Chantix.
I have been taking the drug for several months and am on my last weeks supply. I am glad I read about this because I have been having some very disturbing thoughts and overwhelming feelings.
I took chantix for three weeks and quit smoking. I have been smoke-free for six months and do not miss it. I had stomach upset and gas while taking chantix but not depression.
I took Chantix for a 12 week period almost a year ago. I had a couple of the known side effects, but depression was not one of them. I think depression could come from quitting, regardless of the method used. There are a lot of chemicals leaving the body when you quit. The psychological addiction to nicotine is very strong, and finding other ways to deal with it could also cause depression. It’s too easy to blame medications, but it could be a side effect. Many meds have side effects for a few people (but not for all) and are not removed from the market. Chantix should be one of them.
I took Chantix for three weeks, became seriously depressed with suicidal thoughts. Tried to report it to the FDA but you have to leave your name and address. I don’t particulary trust the FDA to keep things confidential and having serious suicidal thoughts is not something I want people that know me to know about. Guess the stigma for Mental Health problems is still there. I do however want to warn others of the potential threat of taking Chantix. Thanks
To those here who have had adverse to tragic experiences with Chantix, I would very much like to correspond with you. I lost a dear relative New Year’s Eve from a self inflicted gunshot wound and almost lost a good friend due to the side effects that were never explained to them when they began taking the drug. Neither had ever had psychiatric problems and were both least likely to attempt suicide.
I must tell you that I am a writer and I am very interested in your experiences. Most importantly, I want to understand what my cousin was going through before he took his life. Other than violent outbursts and erratic behavior that could be seen, we have no idea what was going on in his mind. He was a very private person. Obviously, I have questions that I believe many of you may be able to answer. Also, there is clearly stories here that need to be told other than my family’s.
I will not, at this point, promise a book, but it is not completely out of the question. There needs to be documentation and it seems to me there is plenty compelling information to document.
1. I will not tremble and falter at the thought of offending big pharmaceutical companies.
2. I will handle all you tell me with the utmost respect and honesty that I would expect in telling someone my story.
3. Should I write these horrors that need to be told, it will not be done without your consent and approval.
4. This is not about money, it is about getting this information to the general unsuspecting public. However, should there be a book… that all will be worked out with the individuals that share in the storytelling.
5. For anyone who tries to participate solely for publicity or delusions of grandeur, please do not contact me. For those that Chantix has helped, I am very happy for you. You should be commended, but please do not send me e-mails chastising me for feeling the need to do this. Those that have suffered need all things to be told… perhaps more than your success stories. I mean no offense.
I read somewhere that there are 6 million people in the U.S. alone, taking Chantix. At this time I have not confirmed that number, but even if it is half that amount, with numbers rising, we are going to be hearing about a lot more of these incidents.
It is quite ironic to me that when you go to the doctor, everything from the common cold to a broken ankle is blamed on smoking. Now, we have this anti-smoking drug wreaking havoc on so many people and it’s blamed on “nicotine withdrawals”. Someone said, “This drug causing people to kill themselves IS a profound way to get them to stop smoking.” I wonder if Pfizer considers these success stories?
So, that is all I have to say. I do hope those of you that have shared on this website contact me. I believe we have important work to do.
Email me at rewtheday@earthlink.net