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FDA Issues Suicide Warnings on Chantix, Zyban
July 9, 2009

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News Summary

Patients taking the stop-smoking drugs Chantix and Zyban/Wellbutrin should be closely monitored for symptoms of serious mental illness that could lead to the risk of suicide, according to a new directive from the U.S. Food and Drug Administration (FDA).

The New York Times reported July 2 that FDA officials stressed that patients should not be discouraged from taking the drugs. "Stopping smoking is a goal we should all be working towards," said FDA official Curtis J. Rosebraugh. "We don't want to scare people off from trying a medication that could help them achieve this goal. You should just be careful."

FDA announced plans to add a stronger warning to Chantix packaging, and drug maker Glaxo will add the warnings currently on Wellbutrin to Zyban -- both formulations of the drug buproprion.

Sales of smoking-cessation drugs have declined in recent years. Chantix, made by Pfizer, controls about 90 percent of the smoking-cessation drug market, with $846 million in annual sales. Still, the drug has fallen short of sales expectations, in part because of prior safety concerns.

COMMENTS ON THIS ARTICLE:

Posted by Musician on 09 Jul 09 09:28 AM EDT
These drugs need to go the way of Vioxx and Redux.

Posted by annroc2003@sbcglobal.net on 09 Jul 09 10:04 AM EDT
I second the comment by Musician... "These drugs need to go the way of Vioxx and Redux"... Hanna

Posted by Howlandwoof on 09 Jul 09 01:07 PM EDT
I have been a Certified Tobacco Treatment Specialist for several years, an alcohol & drug counselor and licensed mental health counselor for years. I'd hesitate to issue blanket statements such as the one posted above by "Musician" about Chantix and Zyban/Wellbutrin - another name for Buproprion Hydrochloride. I've seen several cases where somone has indeed felt suicidal while using Chantix. There have also been rare cases among women in which Buproprion has been a contributing factor in spontaneous orgasm. Most of the cases - but not all, of course - in which people using Chantix have felt suicidal or actually committed suicide included the use of alcohol in conjunction with the Chantix. Anyone remember "synergistice effects" from their Psychopharm 101 class? In one of the more publicized cases of murder/suicide, the person on the Chantix had a blood alcohol level of .24 - about three times the legal definition of intoxication in most states. In other words wasn't he just taking Chantix by itself. He was also legally drunk. And isn't alcohol statistically listed nationally as a "major contributing factor" in both suicides and murder/suicides? So before we throw the baby out with the bath water, maybe we need to see more research on this, and maybe we need slightly heftier disclaimers and warnings about combining medications with alcohol, knowing full well that there will still be some people who will ignore such warnings, either because of addiction or mental health issues. And in those cases, maybe the people doing the assessing and prescribing need to pay closer attention to their patients' lifestyle choices regarding substance use. Just my two cents...

Posted by "doc" on 09 Jul 09 01:59 PM EDT
I've been doing Tobacco Cessation treatment since 1998 before there was Zyban or Chantix. We treated Nicotine Dependence just like all other substance use disorders. We did use the patches to help with the physical cravings but our focus was more on the psychological and social issues than the biological. We used certified CD counselors and a medical model for substance Use Disorders along with Brief solution Focused Therapy and CBT. Our success rates are very good at the 3,6 month and 1 year follow-ups. Our clients stayed in the program for at least 8+ weeks on a weekly basis. People are always looking for the magic bullet and the drug companies are willing to give them one even if it doesn't work and causes more harm than good. The placebo effect is just as high as this drugs success rate. Most tobacco users have a co-occurring D/O that may not be diagnosed or treated except with nicotine and when they quit they start to show symptoms that aren't just from quitting. But most programs don't have adequately trained professionals to Id the symptoms and make an appropriate referral. The results are an increased mortality rate that could have been avoided.

Posted by twocents on 09 Jul 09 02:42 PM EDT
Thanks doc, I take wellbutrin for depression and find it works better for me than the others I have tried. I have never felt suicidal, and so for me, I would be the baby in the bath water that would be thrown out.

Posted by sterling on 09 Jul 09 04:49 PM EDT
I started chantix to quit smoking and became nauseous every time I took my dose, so my MD switched me to wellbutrin. Wellbutrin worked well and I still take it for those times when I become anxious around smokers. I am 28 months smoke free. I have had no serious side effects. The only side effect I have had is some nausea when I take it on an epmty stomach.

Posted by Musician on 09 Jul 09 05:39 PM EDT
Chantix troubles. Spontaneous orgasm? Hardly. Then again he's a guy. I guess that would make a difference concerning the tobacco lobbyist's post... http://www.dispatch.com/live/content/local_news/stories/2007/12/02/CHANTIX.ART_ART_12-02-07_A1_KJ8KNMF.html

Posted by anonymous on 10 Jul 09 09:33 AM EDT
Yes, Chantix does work, and yes it does cause depression. I believe you are predisposed to if if you have a history of depression. I had that experience and had to stop taking it. I do not drink or use drugs, so they have nothing to do with the medication's side effects.

Posted by Julia on 13 Jul 09 11:05 AM EDT
I agree with 'anonymous' about the suicidal 'ideation' that has warnings inside the pack, in Champix in Australia. Luckily I didn't suffer from this but my son did.The awful nausea I solved by breaking each tablet into 3, then taking 6 doses over the 24 hr period.

Posted by Silver on 12 Aug 09 10:14 AM EDT
I take Wellbutrin for depression and it has noticeably helped me feel better! And, after 35 years of smoking, I quit 8 months ago! Spontaneous orgasm?? I wish!

Posted by Jane on 06 Sep 09 12:07 AM EDT
My husband committed suicide in 2008 after taking Chantix to stop smoking. He became agressive and he was a passive person. We were married 35 years and I miss him so. Chantix killed him. I can not convince you in 250 words but I have done my research and I know this is true. Please please do not use this drug. My husbands death matters and Pizer does not care.

Posted by anonymous on 09 Nov 09 10:28 PM EST
I was on Chantix for 4 months. The first two weeks I had nothing but nausea all day, all night. After that, the nausea vanished. However, I had wild dreams and I couldn't sleep half the nights. I would find myself suddenly crying, feeling so bad for myself, and I'd wonder what the hell just happened? This was without use of street/other prescribed drugs and alcohol. My doctor knew I had depression problems, but prescribed it to me anyway. Now I'm sorry for taking it. The threat of killing myself is just not worth it. I'd rather die 30 years later from cigarettes than a bullet in my head by my own hand. It's just a stupid risk to take. I'll try Wellbutrin again. I've had this in the past for depression issues, and perhaps it's safer for me to go back on that than Chantix.

Posted by cjjbc on 29 Dec 09 03:57 PM EST
Jane my heart goes out to you. someone very close to me took Chantix and is now facing 20 yrs in prison for something he would have never done in his life until he started taking chantix. Also he resently tried to commit suicide and is now in a mental hospital. This drug has side effects that can last for more then a year after you stop taking it. This Drug should be taken off the market. But I guess money means more to phizer then human lives.

Posted by Ang2009 on 05 Jan 10 09:44 PM EST
A week ago I lost a friend to suicide. "shock" is not a strong enough word to describe it. He was a wonderful man who was always, cool and calm, happy, and had a positve outlook on life even in hard times. I found out that he had been taking chantix so i started to do some research for myself. I am convinced that this medicine was the cause! And yes, "Howlandwoof" he was drinking too the night he commited suicide but if the medicine can cause severe depression, along with all the other side effects, is it that hard for you to believe that is what triggers the choice to drink and then the alcohol mixed with the drug causes the chantix side effects to worsen? How can the people at phizer truly justify chantix after all of the horrendous side effects it has caused!!!? Yes, my heart is broken over the loss of my friend, but it is also broken for all of the people that took this drug in hopes of bettering their health but instead, like my dear friend, things went tragically wrong. My friend does not deserve for that to be what people remember of him... suicide. I want justice for him and for everyone else effected.

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