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November 3rd, 2011
10:56 AM ET

Anti smoking drug may increase suicide risk, study says

The popular quit-smoking drug Chantix may increase the risk of suicide and suicidal thoughts in some patients, says a new report.

Researchers looked at more than 3,000  reports of "neuropsychiatric adverse events" - unexpected problems that result in risk or harm to the patient -relating to smoking cessation drugs, and found that more than 90% of the reports were associated with Chantix use.

"We compared people who took nicotine replacement therapy, Zyban and Chantix," said Dr. Curt Furberg, a study author, and professor of public health sciences at Wake Forrest Baptist Medical Center. "There was an increase in suicides even with nicotine replacement therapies, but Chantix was 8-10 times worse."

But the findings were in stark contrast to a report released just last week by the Food and Drug Administration, which claimed no difference in suicide risk between the three therapies. Furberg says the FDA's report was woefully underpowered.

[The FDA report] looked at hospitalized events," he said. "82% of all serious adverse events do not lead to hospitalization, so that means they missed 82% of all of the serious adverse events."

And though the FDA makes this very same point on its own report, the agency says the drug is safe when used appropriately.

"We continue to believe that when used as directed in the currently approved labeling, Chantix is a safe and effective treatment to help patients stop smoking," FDA spokeswoman Karen Riley said in an email to CNN.

Concerning reports about the drug's safety are nothing new. Since it was approved in 2006, Chantix has been banned by the Federal Aviation Administration for use in pilots, because of  concerns about possible blackouts. The U.S. military also has banned the drug for pilots, air-traffic controllers and missile teams; its use has been tightly controlled among truck drivers for similar reasons.

Since 2009, Chantix and Zyban have been required to carry "black box" warnings on their packaging, noting risks of depression and suicide.

Earlier this year, another report by Furberg and his associates found a 72% increased risk of serious cardiovascular events in Chantix users. Other previous studies have shown a link between the drug and an increase in violent and aggressive behavior.

Pfizer, the drug company that makes Chantix, said in a statement to CNN that any reports of suicidal behavior do not necessarily implicate the drug.

"It is important to remember that post-marketing reports do not establish a cause and effect relationship," wrote MacKay Jimeson, a drug company spokesman. He went on to cite the FDA's statement last week that “the agency continues to believe that the drug’s benefits outweigh the risks and current warnings in the Chantix label are appropriate.”

Furberg and his co-authors are calling on the FDA to change warning labels for Chantix, and say the drug may not be the best first-line defense against smoking.

"If you're going to use Chantix, it should be the last resort," Furberg said, "and even then you need to monitor a patient's mental status. That’s a reasonable policy, and we'd like the FDA to do that."

Furberg went onto say that people taking the drug now should talk with their doctor to determine whether Chantix is the best quit-smoking aid for their particular needs.

According to Pfizer's website, more than 7 million people in the United States have been prescribed Chantix since it was approved in 2006.


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soundoff (21 Responses)
  1. MacKay Jimeson

    This is MacKay Jimeson from Pfizer.

    Pfizer reaffirms the importance of CHANTIX (varenicline) as a first line treatment option for adult smokers who want to quit. The analysis of post-marketing reports by Moore et al, made available on line today in PLoS One does not offer reliable scientific information. Pfizer stands behind the benefit-risk profile of CHANTIX.

    The US Food and Drug Administration (FDA) stated on October 24 in a Drug Safety Communication that “based on FDA’s assessment of currently available data, the Agency continues to believe that the drug’s benefits outweigh the risks and current warnings in the CHANTIX label are appropriate.” This statement was issued in connection with the results of two FDA-sponsored observational studies conducted by the Department of Veterans Affairs and the Department of Defense.
    The analysis by Moore et al is based solely on post-marketing reports of adverse events that have been available to the FDA for some time. Post marketing reports do not establish a cause and effect relationship between a medicine and a reported adverse event. These reports can come from any source ranging from patients to healthcare providers, and from phone calls to internet postings. Often these reports lack sufficient medical information to enable a meaningful assessment. Due to these limitations, any conclusions based on comparisons between different drugs and reporting rates are not reliable.

    Clinical trial information provides more reliable data; results from CHANTIX clinical trials to date do not show that CHANTIX causes these reported serious neuropsychiatric events. Pfizer is committed to studying CHANTIX in patients with a history of neuropsychiatric illnesses. Recently, Pfizer completed a small study of CHANTIX use in smokers with stable schizophrenia, results of which are available on clinicaltrials.gov. A study to evaluate the safety and efficacy of CHANTIX for smoking cessation in patients with depression is currently underway and results are expected in late 2012. Importantly, Pfizer is conducting a large, double blind placebo controlled safety clinical trial of CHANTIX to assess neuropsychiatric safety in patients with and without psychiatric disorders, and results of this large study are expected in 2017.
    The health benefits of quitting smoking are immediate and substantial. Given the significant public health risks of smoking, treatment options are needed. CHANTIX is recommended as a first-line aid to smoking cessation treatment by the US Public Health Service in its Clinical Practice Guideline.

    November 3, 2011 at 11:56 | Report abuse | Reply
    • raja jertila

      Hi, I was a smoker and I think unless u were a smoker, you really have no idea how it works, so for the lady that was giving advises she was to me completely wrong. I never used a medicine to quit, but what helped me to quit is first thought of quitting, second started trying, 3rd couldn't until I bought a pack of cigarette and put it in my house so I wouldn't be craving it. and finally since than I never did smoke. easy as it can be. I tried stop smoking through thinking I will quit when I finish smoking my last pack. as soon as I did, I was going to buy cigarettes in the middle of the night. so one day I bought a pack and put it in my kitchen and thought I dare my self I won't touch it, and I did not touch it. I forgot to mention 1 other thing, you have to make sure you pick the right time to quit, in other words if you are in a stressful time of the month or in a middle of a crisis, just wait because we tend to go smoke when we r upset or stressed thinking it would help us. it really makes a difference, in few days we brak the habit and we no longer think of it when we r upset because it is no longer in our routine....... That's my story. I use to wake up thinking of my coffee and cigarette, and now I do not even remember it unless someone speacks about or something.

      November 3, 2011 at 15:23 | Report abuse |
    • j. Summerhays

      Dear MacKay Jimeson,
      I'm glad to hear that pfizer is conducting a large scale double-blind clinical trial concerning the neuropsychiatric safety of their patients. I think that depending on the person (as with any medication) chantix can cause serious side effects such as depression. I grew up in a mormon household although i'm not religious, quite the opposite. i started smoking at 14 years old. So what do my parents do when they find out about this magnificent pill that helps you quit? They take me to the doctor and tell him to put me on it. the problem could be the medication having a bad effect. i personally think pfizer marketed it as the safest "front line defense" when for someone at 14 or 15, it can cause those "serious side effects" while the body is still developing the box shouldn't have another stupid warning on it. IT SHOULD HAVE A RESTRICTION TO CHILDREN! Now i'm not saying it should be taken of the market or anything it helped me quit but i started right back up after 3 months of taking that pill three times a day like my doctor said. But then i noticed something wasn't right. went back to the doctor and he told me that i had depression. wow who would have guessed? Now pay attention if your reading. (since we all know you and Pfizer won't.) I love drugs as much as any other stoner, junkie, low-life, whatever it is your society likes to label us as (we're people too btw.), but i have never taken anything that has messed up my life more than that little pill your trying to defend so much. Here are some examples of drugs that after taking have never made me feel as worse as Chantix did. Marijuana, alcohol, Loratab, Percocet, Vicodin, Oxycotin, LSD, DMT, Methamphetamine, Methylndioxymethampheptamine, Hallucinogenic Mushrooms, Nitrous Oxide, GHB, DOC, LSA, Heroin, Cocaine, Crack, Adderal, just to name a few. Now if you even know what a tenth of these drugs to the human body and mind you'll realize my comparison is that chantix was worse (FOR ME) than all of these drugs. one of these days Pfizer will be sued for the slow mental and finally physical death of those affected negatively by this med. Because we outnumber those who the pill did good for. I hate your company for taking my life. peace out MacKay.

      November 3, 2011 at 16:13 | Report abuse |
    • Drug Reactions

      I find it fascinating the arguments that go on about "risk" and "benefit" for these drugs. I had a horrible reaction to another drug, not Chantix. Unfortunately, because doctors are not made aware of these side effects, my dosage of the drug was actually increased. I almost died from the adverse reaction to this drug, while doctors stood by, baffled.

      You can conduct your studies and talk about these so called benefits, but when someone in your family goes through the hell that I went through, I hope you accept the blame. Doctors are not educated. It's not the risks that are the problems, it's the basic lack of information made available to the medical community. Reactions to drugs happen. I understand that, but your denial directly effects how doctors are educated and react to these drugs. I don't blame the doctors for what happened to me. I blame you and your colleagues.

      November 3, 2011 at 17:19 | Report abuse |
    • ser

      People...listen up..and listen good.....like weight loss...there is no magic pill that will make you quit smoking....like weight loss you will have to put in blood, sweat and tears...i smoke for the better part of 20yrs...i am 36....i am going on almost 1 yr of not smoking...i had my last smoke on Dec 11, 2010....i took no pills, drinks, serums, or potions...I made a choice...i made a choice not to smoke anymore....it is the only way you will quit....if you want it bad enough you will do it..if not...then you won't....like losing weight...you gotta change your life....change your environment...you can't just pop a pill and lose weight...well you can...but you can't keep it off...the point is...if you wanna quit you can..you need to be strong and use some determination...YOU CAN DO IT....

      November 4, 2011 at 12:35 | Report abuse |
  2. M. G. Pena

    After my 8-9 weeks on Chantix, I have experienced severed problems. For last 2-3 weeks suicidental thoughts are on my mind every waking minute. Only thing keeping me from acting on these thoughts are the correct way to kill myself with success, and leaving my personal affairs in order. I have followed & read all material provided by Chantix, taken it as instructed and am part of their on-line suport group. Material states to check w/ doctor before stopping. I've been referred to a psychiatrist. I've tried 4 different doctors to no avail. I am 67 yrs old. One doctor does not see anyone over 60. The rest won't take Medicare even though AETNA, my secondary will cover fees. FDA and Chantix are wrong in their statements. GOD help me on what's next.......bye.

    November 3, 2011 at 15:25 | Report abuse | Reply
    • Marion

      Oh, I hear you!! I am 68 and have been struggling with quitting smoking for the last 3 years.....on and off, on and off, can't seem to stay off. And what do the doctors say to me: "have you tried Chantix"?". NO WAY.....just listen to their tv ads and on the side effects they must list at end of commercial. It is a joke, in my opinion. I have used the patch with some success....but if you don't have a strong will to stop, the patch will do you no good. And if you use it, be sure to take it off when going to sleep or you will be waking up all night because of the "side effect" of very vivid dreams, often nightmares, that you will get. I am very discouraged with my progress, but it is all up to me and my will power, so I have no real "excuse".

      November 4, 2011 at 03:42 | Report abuse |
    • Marion

      I also hear you about the Medicare issue.......trying to find a doctor in private practice who will take new patients on Medicare is like finding a needle in a haystack. Must go to major hospitals" clinics to find doctors who take Medicare and Medicaid. The red tape at these hospital clinics is enough to cause even more medical issues than the one's you came in to get treatment for. Can you imagine what it will be like when 30 million more people are covered with insurance by the Health Care law (so called "Obamacare") coming into effect over next few years? There are not even enough primary care doctors to go around NOW.

      November 4, 2011 at 03:48 | Report abuse |
  3. BOSS ISN'T JUST FOUR LETTERS

    I THINK THIS IS A HELPFUL ARTICLE

    November 3, 2011 at 16:53 | Report abuse | Reply
  4. BOSS ISN'T JUST FOUR LETTERS

    KTHNXBAI

    November 3, 2011 at 16:54 | Report abuse | Reply
  5. negligence///!!!!!!

    THE FDA AND THE COMPANY SHOULD BE ASHAME OF THEMSELVES. I CAN BELIEVE THEY RISK PEOPLES LIVES FOR MONEY. SHAME, SHAMe!!!!!!!!!!!

    November 3, 2011 at 23:35 | Report abuse | Reply
    • Diana

      so 9 weeks Cold Turkey for me so far. pretty much just threw them away and used Xanax to take the edge off when I need it. As far as some ppleoe stating to Dr's that they become sucidal If you quit smoking to save your life, why would you stop smoking just to kill yourself?After 3 days on Zero nicotine your free of it. The only part one has to overcome with time is the minds false feeling of please associated with smoking.My cravings today are so far apart and last for less than a minute.

      April 9, 2012 at 11:29 | Report abuse |
  6. Marion

    Drug Reactions wrote:
    "Doctors are not educated. It's not the risks that are the problems, it's the basic lack of information made available to the medical community. "

    Don't be naive. These doctors, all doctors, are fully informed of the risks and side effects associated with all the drugs they prescribe ("push") for their patients. They simply ignore them because they have nothing else to offer you but drugs, drugs, drugs, to help with any health problem you are having. It is their way of slipping you out the door so they can move on to the next patient. Their favorite way to answer a patients concerns about side effects is: "Well, all drugs have side effects", "just lets see how you do on this drug". They do not memorize the side effects of all the drugs they prescribe......and they certainly do get the complete information from pharmaceutical reps/sales people that sell them on these drugs. Think about it: where would the medical profession be without the drugs they prescribe for you hoping that if they treat the symptoms of any medical issue, then they won't have to bother to actually diagnose the underlying CAUSE of your medical issue. It's all about "moving patients through the line" quickly. When is th last time you went to a doctor who treated the symptoms fiirst and actually mthen took the time to figure out the cause of your medical issues? "take this" and "make an appointment for your next visit" in thirty days. You take the "symptom drug", you start feeling odd symptoms that you don't even realize are side effects of the drugs, because the doctor NEVER INFORMED YOU OF THE SIDE EFFECTS.....even when you ask beforehand. Then when someone tells them of side effects they are getting because they looked it up on their own, they tell you "well very few or no patients have reported that to me". Then they start treating the side effect symptoms you reported with MORE DRUGS. iI could go on and on of my experiences with this issue, but can't write a book here.

    November 4, 2011 at 03:32 | Report abuse | Reply
    • help14

      your argument is pointless the doctor will tell you what he/she knows im pretty sure that when you pick up your percription becuase the doctor doesn't give it to you by hand the pharmacy always states do you have any questions? if you say no they still point out to the big label that is on the bag that's holding your drugs and it mentions every little possible thing that can happen if you take the pill did you try reading that?

      November 4, 2011 at 03:57 | Report abuse |
  7. help14

    its amazing that people will take any pill that the doctor prescribes do your own homework people doctors are people just like me and you they get tired and dont want to deal with b.s are you really going to trust a doctor with your life? if you die he/she can care less and go on with their day. I hate pills and will not stick a dam pill in my mouth ever ill find a natural cure or smoke some weed its amazing that their are more "feel better" pills then cure pills they keep us sick so if your looking to just feel better smoke some dam weed and stick it to the man im telling you marijuana is the best thing in the world it does not make you crazy or suicidal it does not make you kill people i think the gov hates it so much becuase if anything it makes you anti government lol.

    November 4, 2011 at 03:50 | Report abuse | Reply
  8. help14

    and another thing it makes you actually enjoy life again if your a suicidal loney before you do anything drastic smoke a J even a little bit the first time might make you bug out becuase your a newbie but i promise its the best thing you'll ever discover

    November 4, 2011 at 03:53 | Report abuse | Reply
  9. James

    I did Chantix twice, quit for seven months then started smoking again for a year. Did it again, but this time did it for two cycles, think it is two months. I have been smoke free for 3 years now and I owe it to Chantix. Only problem I had was a upset stomach for about 20 minutes after I took the pill.

    I think the people that blame suicidal thoughts on Chantix, are already depressed and are looking for a scapegoat.

    November 4, 2011 at 12:44 | Report abuse | Reply
  10. Mexia

    This is old news. Dallas musician Carter Albrecht lost his life while using Chantix. You can find his story and much more here:

    http://www.dallasobserver.com/search/index?keywords=Chantix&x=19&y=14

    November 6, 2011 at 01:23 | Report abuse | Reply
  11. Babydoc

    I smoked for more than forty years. My doctor prescribed Chantix for me and my last smoke was almost four years ago. No upset stomach, no suicidal thoughts, no cigarettes! Thanks Pfizer.

    November 6, 2011 at 10:05 | Report abuse | Reply
  12. Avser Bastian

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    OUT OF AMERICA WITH WHITES NOW !!!


    OR
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    THIS NEWS IS RELATED TO WALL-STREET PROTESTS...NOT ANTI WALL-STREET, BUT ANTI WHITES !!!

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    November 6, 2011 at 17:48 | Report abuse | Reply
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