Suicide Warning For Antismoking Drug

[sbk]

Suicide Warning for Antismoking Drug

FDA Says Patients Taking Chantix Should Be on the Lookout for Mood or Behavior Changes

By Todd Zwillich

WebMD Medical News

Reviewed by Louise Chang, MD

Feb. 1, 2008 -- Federal officials warned Friday that a popular antismoking drug may be linked to suicides in some patients.

The drug, called Chantix, has been used by more than 5 million patients as a smoking cessation aid, according to manufacturer Pfizer Inc. The drug will now carry new labels warning doctors and consumers of reports of suicidal thoughts and behaviors.

FDA officials said they had received nearly 500 reports of suicidal thoughts, behaviors, and completed suicides, 420 of which were in U.S. patients. Thirty-four cases of completed suicide were recorded in the U.S., along with five cases overseas.

The reports don't prove that Chantix was the cause of the suicide. But FDA officials say their investigation showed several suicide cases in patients with no history of psychiatric problems.

"We've become increasingly concerned as we've seen that there are a number of compelling cases that truly look as though they are the result of exposure to the drug," said Bob Rappaport, MD, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.

"Clearly these are very concerning findings for this product, which is being very widely used," he told reporters on a telephone conference call.

The agency asked Pfizer to increase the prominence of warnings on the Chantix label. The company made similar changes to the label two weeks ago.

The drug was approved in May 2006 as a smoking cessation agent. It is different from the variety of nicotine gums, patches, and lozenges on the market. While those products help replace nicotine when patients quit, Chantix acts directly on brain centers affected by nicotine.

In a statement issued two weeks ago, Pfizer said any risks associated with Chantix should be balanced with the known risks of smoking.

"Chantix is a real breakthrough medicine that has helped many smokers who want to quit. We hope that today's labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication," a release from the company stated.

Rappaport said the FDA considers Chantix "extremely important and extremely effective" in helping people quit smoking. But he said patients taking the drug and their doctors should be on the lookout for any behavior or mood changes.

"They should discuss with their health care provider as soon as possible whether they should continue with the drug or not" if mood changes occur, he said.

The FDA's public health advisory emphasizes the following safety information on Chantix:

* Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.

* Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors, and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix.

* Patients taking Chantix should immediately report changes in mood and behavior to their doctor.

* Patients taking Chantix may experience vivid, unusual, or strange dreams.

* Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

The FDA is working with Pfizer to finalize a medication guide for patients.

SOURCES:

Bob Rappaport, MD, director, Division of Anesthesia, Analgesia and Rheumatology Products, FDA.

News release, Pfizer.

FDA: "Public Health Advisory: Important Information on Chantix (varenicline)."

© 2008 WebMD, LLC. All rights reserved.

[NowImEasy]

Suicide Warning for Antismoking Drug

FDA Says Patients Taking Chantix Should Be on the Lookout for Mood or Behavior Changes

By Todd Zwillich

WebMD Medical News

Reviewed by Louise Chang, MD

Feb. 1, 2008 -- Federal officials warned Friday that a popular antismoking drug may be linked to suicides in some patients.

The drug, called Chantix, has been used by more than 5 million patients as a smoking cessation aid, according to manufacturer Pfizer Inc. The drug will now carry new labels warning doctors and consumers of reports of suicidal thoughts and behaviors.

FDA officials said they had received nearly 500 reports of suicidal thoughts, behaviors, and completed suicides, 420 of which were in U.S. patients. Thirty-four cases of completed suicide were recorded in the U.S., along with five cases overseas.

The reports don't prove that Chantix was the cause of the suicide. But FDA officials say their investigation showed several suicide cases in patients with no history of psychiatric problems.

"We've become increasingly concerned as we've seen that there are a number of compelling cases that truly look as though they are the result of exposure to the drug," said Bob Rappaport, MD, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.

"Clearly these are very concerning findings for this product, which is being very widely used," he told reporters on a telephone conference call.

The agency asked Pfizer to increase the prominence of warnings on the Chantix label. The company made similar changes to the label two weeks ago.

The drug was approved in May 2006 as a smoking cessation agent. It is different from the variety of nicotine gums, patches, and lozenges on the market. While those products help replace nicotine when patients quit, Chantix acts directly on brain centers affected by nicotine.

In a statement issued two weeks ago, Pfizer said any risks associated with Chantix should be balanced with the known risks of smoking.

"Chantix is a real breakthrough medicine that has helped many smokers who want to quit. We hope that today's labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication," a release from the company stated.

Rappaport said the FDA considers Chantix "extremely important and extremely effective" in helping people quit smoking. But he said patients taking the drug and their doctors should be on the lookout for any behavior or mood changes.

"They should discuss with their health care provider as soon as possible whether they should continue with the drug or not" if mood changes occur, he said.

The FDA's public health advisory emphasizes the following safety information on Chantix:

* Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.

* Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors, and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix.

* Patients taking Chantix should immediately report changes in mood and behavior to their doctor.

* Patients taking Chantix may experience vivid, unusual, or strange dreams.

* Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

The FDA is working with Pfizer to finalize a medication guide for patients.

SOURCES:

Bob Rappaport, MD, director, Division of Anesthesia, Analgesia and Rheumatology Products, FDA.

News release, Pfizer.

FDA: "Public Health Advisory: Important Information on Chantix (varenicline)."

© 2008 WebMD, LLC. All rights reserved.

The medication is a very dangerous drug. My experience was horrific. I followed the prescribed dosage for over two weeks. After the first few days, I started to feel lethargic and apathetic. These symptoms worsened to what could be described as deep depression, but I didn't associate this to Chantix, and kept taking the drug. I went to see my doctor who had prescribed the Chantix, but he never thought there could be a connection to my symptoms. He said that if I didn't 'snap out of it soon' we'd try prozac or something like that. I investigated online, found a Chantix users forum, and recognized the symptoms that others described, and quit taking the drug. I'm a happy guy mostly, but was such a zombie after two weeks on the drug, that I could imagine that someone could contemplate suicide. It was many weeks after cessation of the drug before I started to feel better, and even now, there are times when I get recurrences of the terrible effects of the drug.

I would imagine that Phizer will soon be in a world of hurt over this medication.

[skippybangkok]

Guess its one way to quit smoking ! makes u wonder how it can be approved by the FDA with such strong side effects

[koto]

Suicide Warning for Antismoking Drug

FDA Says Patients Taking Chantix Should Be on the Lookout for Mood or Behavior Changes

By Todd Zwillich

WebMD Medical News

Reviewed by Louise Chang, MD

Feb. 1, 2008 -- Federal officials warned Friday that a popular antismoking drug may be linked to suicides in some patients.

The drug, called Chantix, has been used by more than 5 million patients as a smoking cessation aid, according to manufacturer Pfizer Inc. The drug will now carry new labels warning doctors and consumers of reports of suicidal thoughts and behaviors.

FDA officials said they had received nearly 500 reports of suicidal thoughts, behaviors, and completed suicides, 420 of which were in U.S. patients. Thirty-four cases of completed suicide were recorded in the U.S., along with five cases overseas.

The reports don't prove that Chantix was the cause of the suicide. But FDA officials say their investigation showed several suicide cases in patients with no history of psychiatric problems.

"We've become increasingly concerned as we've seen that there are a number of compelling cases that truly look as though they are the result of exposure to the drug," said Bob Rappaport, MD, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.

"Clearly these are very concerning findings for this product, which is being very widely used," he told reporters on a telephone conference call.

The agency asked Pfizer to increase the prominence of warnings on the Chantix label. The company made similar changes to the label two weeks ago.

The drug was approved in May 2006 as a smoking cessation agent. It is different from the variety of nicotine gums, patches, and lozenges on the market. While those products help replace nicotine when patients quit, Chantix acts directly on brain centers affected by nicotine.

In a statement issued two weeks ago, Pfizer said any risks associated with Chantix should be balanced with the known risks of smoking.

"Chantix is a real breakthrough medicine that has helped many smokers who want to quit. We hope that today's labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication," a release from the company stated.

Rappaport said the FDA considers Chantix "extremely important and extremely effective" in helping people quit smoking. But he said patients taking the drug and their doctors should be on the lookout for any behavior or mood changes.

"They should discuss with their health care provider as soon as possible whether they should continue with the drug or not" if mood changes occur, he said.

The FDA's public health advisory emphasizes the following safety information on Chantix:

* Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.

* Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors, and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix.

* Patients taking Chantix should immediately report changes in mood and behavior to their doctor.

* Patients taking Chantix may experience vivid, unusual, or strange dreams.

* Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

The FDA is working with Pfizer to finalize a medication guide for patients.

SOURCES:

Bob Rappaport, MD, director, Division of Anesthesia, Analgesia and Rheumatology Products, FDA.

News release, Pfizer.

FDA: "Public Health Advisory: Important Information on Chantix (varenicline)."

© 2008 WebMD, LLC. All rights reserved.

The medication is a very dangerous drug. My experience was horrific. I followed the prescribed dosage for over two weeks. After the first few days, I started to feel lethargic and apathetic. These symptoms worsened to what could be described as deep depression, but I didn't associate this to Chantix, and kept taking the drug. I went to see my doctor who had prescribed the Chantix, but he never thought there could be a connection to my symptoms. He said that if I didn't 'snap out of it soon' we'd try prozac or something like that. I investigated online, found a Chantix users forum, and recognized the symptoms that others described, and quit taking the drug. I'm a happy guy mostly, but was such a zombie after two weeks on the drug, that I could imagine that someone could contemplate suicide. It was many weeks after cessation of the drug before I started to feel better, and even now, there are times when I get recurrences of the terrible effects of the drug.

I would imagine that Phizer will soon be in a world of hurt over this medication.

Suicide warning!! Suicide warning!! Smoking is a Suicide warning and 10 times out of 10 it will win, taking medication gives you a chance to quit before you commit suicide by smoking, "Not easy" You need to want to live healthy more then anything else and at the same time realize that your also contaminating the rest of us in the process, Smoking is a very slow Suicide, fast for some, The odds of the medication killing you is much less then Smoking (Just a thought) Not to offend just another way to look at it, Health and Happiness to all

[Patong Bob]

My Thoracic Surgeon told me to stop taking Champix after I had bad depression. This is someone who operated on me for lung cancer last year.

Any other ideas ?

[Manda]

There's also Tabex. It's supposed to be a more natural variant (of varenicline) called Cytisine. It's also much cheaper.

Heard some great results about it.

[peter991]

I have to second NowinEasy's comments: Champix can cause despression leading to suicidal thoughts. For me, Champix enabled me to stop smoking. I started smoking when I was 17yo. I am now 54yo. In the past I have tried nicotine gum, nicotine patches and Zyban. Champix worked. I have been smoke-free since Easter this year. Champix actually has the highest success rate of any product to help people stop smoking: 34%.

But - the trade off is depression. In my case it was severe. Even now - 16 weeks later - I am still quite depressed. My blood pressure has dropped from 175/115 to 135/75 and I have started exercising and dropped from 91kg to 85kg.

Is it worth it? I think YES. I'll get over the depression and I'll stay smoke-free - but others may not be so lucky.

Peter

[scotwumman]

I have had prescribed what I think is the UK version Champix and after reading these comments will not take them and try to rely on willpower need to stop as have just been diagnosed with emphacima (?) maybe, lung damage certainly and having ongoing tests.

I have been smoking for about 45 years so will have to hold on tight.

Lasted two hours so far.

[scotwumman]

Posting again so as not to influence anyone against Champix have spoken to doctor to explain not using the method and was assured by the nurse in the practice that it does have a good success rate. Just wouldn't work for me.

[NowImEasy]

Koto, Sorry, but you sound preachy. If you're a non smoker, why are you even on this topic. Don't you think that mature smokers know they have a problem? Or do you think your imput will enlighten us? We smokers are aware of the consequences and are not stupid. Do you know that the great saviour of the evil USA, Sen Obama is a smoker? Do you think he's stupid.

Sorry, but I am offended by your comments.

Suicide Warning for Antismoking Drug

FDA Says Patients Taking Chantix Should Be on the Lookout for Mood or Behavior Changes

By Todd Zwillich

WebMD Medical News

Reviewed by Louise Chang, MD

Feb. 1, 2008 -- Federal officials warned Friday that a popular antismoking drug may be linked to suicides in some patients.

The drug, called Chantix, has been used by more than 5 million patients as a smoking cessation aid, according to manufacturer Pfizer Inc. The drug will now carry new labels warning doctors and consumers of reports of suicidal thoughts and behaviors.

FDA officials said they had received nearly 500 reports of suicidal thoughts, behaviors, and completed suicides, 420 of which were in U.S. patients. Thirty-four cases of completed suicide were recorded in the U.S., along with five cases overseas.

The reports don't prove that Chantix was the cause of the suicide. But FDA officials say their investigation showed several suicide cases in patients with no history of psychiatric problems.

"We've become increasingly concerned as we've seen that there are a number of compelling cases that truly look as though they are the result of exposure to the drug," said Bob Rappaport, MD, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.

"Clearly these are very concerning findings for this product, which is being very widely used," he told reporters on a telephone conference call.

The agency asked Pfizer to increase the prominence of warnings on the Chantix label. The company made similar changes to the label two weeks ago.

The drug was approved in May 2006 as a smoking cessation agent. It is different from the variety of nicotine gums, patches, and lozenges on the market. While those products help replace nicotine when patients quit, Chantix acts directly on brain centers affected by nicotine.

In a statement issued two weeks ago, Pfizer said any risks associated with Chantix should be balanced with the known risks of smoking.

"Chantix is a real breakthrough medicine that has helped many smokers who want to quit. We hope that today's labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication," a release from the company stated.

Rappaport said the FDA considers Chantix "extremely important and extremely effective" in helping people quit smoking. But he said patients taking the drug and their doctors should be on the lookout for any behavior or mood changes.

"They should discuss with their health care provider as soon as possible whether they should continue with the drug or not" if mood changes occur, he said.

The FDA's public health advisory emphasizes the following safety information on Chantix:

* Patients should tell their doctor about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of a current psychiatric illness even if it is currently under control and may cause an old psychiatric illness to reoccur.

* Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors, and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix.

* Patients taking Chantix should immediately report changes in mood and behavior to their doctor.

* Patients taking Chantix may experience vivid, unusual, or strange dreams.

* Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

The FDA is working with Pfizer to finalize a medication guide for patients.

SOURCES:

Bob Rappaport, MD, director, Division of Anesthesia, Analgesia and Rheumatology Products, FDA.

News release, Pfizer.

FDA: "Public Health Advisory: Important Information on Chantix (varenicline)."

© 2008 WebMD, LLC. All rights reserved.

The medication is a very dangerous drug. My experience was horrific. I followed the prescribed dosage for over two weeks. After the first few days, I started to feel lethargic and apathetic. These symptoms worsened to what could be described as deep depression, but I didn't associate this to Chantix, and kept taking the drug. I went to see my doctor who had prescribed the Chantix, but he never thought there could be a connection to my symptoms. He said that if I didn't 'snap out of it soon' we'd try prozac or something like that. I investigated online, found a Chantix users forum, and recognized the symptoms that others described, and quit taking the drug. I'm a happy guy mostly, but was such a zombie after two weeks on the drug, that I could imagine that someone could contemplate suicide. It was many weeks after cessation of the drug before I started to feel better, and even now, there are times when I get recurrences of the terrible effects of the drug.

I would imagine that Phizer will soon be in a world of hurt over this medication.

Suicide warning!! Suicide warning!! Smoking is a Suicide warning and 10 times out of 10 it will win, taking medication gives you a chance to quit before you commit suicide by smoking, "Not easy" You need to want to live healthy more then anything else and at the same time realize that your also contaminating the rest of us in the process, Smoking is a very slow Suicide, fast for some, The odds of the medication killing you is much less then Smoking (Just a thought) Not to offend just another way to look at it, Health and Happiness to all

[Sheryl]

Obviously, one has to weigh the risks and decide which is the lesser of the two, and that equation will be different for every individual.

Chantrix can cause serious depression and even suicide, but it does not have this effect in everyone or even in most users. The important thing is to be aware of the contraindications (i.e. don't try it if a history of depression), and if you do take it, to be alert to the possibility that it may cause serious depression and to know to stop taking it if this occurs.

Just knowing that the depression is drug-induced and will stop when the drug is discontinued might have prevented some of the suicides that have occurred, so the posting of thsi information in this forum is very constructive.

One warning - depression can quickly overwhelm rational thinking, so if you take this drug and start to experience depression don't let things get too bad on the assumption that you can handle it knowing it is just an effect of the drug. That knowledge will probably see you through a mild depression but in severe depression one is apt to lose all perspective and be swallowed up by it. Don't take that risk, better to back off the medication.

As this effect does not occur in all users, and the severity when it does occur is very variable, it should not necessarily prevent people from using it if they have otherwise been unable to quit smoking...jJust use it carefully with awareness of these potential risks.

[ThaiPauly]

I stopped taking Champix after 3 weeks....and started smoking again.

There has to be a better way, the nightmares I was experiencing EVERY night would cause me to sit bolt upright in bed sweating and screaming.

I dreaded going to bed...

Two weeks after I stopped using the drug I am suffering massive depression, maybe some of that is due to my failure to stop, but I know a lot of it is not.

[burnalot]

This is SUCH a pile of crap!

Champix/Chantix, whatever by Phizer is not going to make you want to off yourself. Nor is it likely to cause depression.

I was on it for months, and what I will say, is that it can cause tremendous stomach pain without a meal in you.

If you are depressed, suicidal, than yes, maybe Champix won;t help the situation. But for normal, relatively stressed out people, it is not going to make you put a barrel in your mouth. This is pure propganda created no doubt by Pfizer's competition, and nothing more.

The drug was certainly helpful in quitting smoking, but you need to make an effort. It is not going to magically lift the addiction away from you!

[Moonrakers]

Are you qualified to make that statement burnalot?

A lot of people do suffer when taking this medicine and just because you had no ill side effects does not necessarily mean that is the same for everybody else.

Maybe the drug itself is not to blame but it is quite irresponsible to think so until we know for sure don't you think?

[Sheryl]

This is SUCH a pile of crap!

Champix/Chantix, whatever by Phizer is not going to make you want to off yourself. Nor is it likely to cause depression.

I was on it for months, and what I will say, is that it can cause tremendous stomach pain without a meal in you.

If you are depressed, suicidal, than yes, maybe Champix won;t help the situation. But for normal, relatively stressed out people, it is not going to make you put a barrel in your mouth. This is pure propganda created no doubt by Pfizer's competition, and nothing more.

The concerns about depression and suicide are not coming from Pfizer's competition but from Pfizer's own post-marketing surveillance.

Depression occurs in only a minority of patients taking the drug but is by no means limited to people with prior mental problems or history of depression. there have been cases of people with no known risk factors becoming severely depressed and even suicidal on the drug. There are also some people who, rather than depressed, become manic (very agitated).

Since the drug works by altering neurotransmitters in the brain it is not suprising that (1) the effect will vary by individual and (2) in some cases undesirable neuropsychiatric symptoms may occur; the most common being insomnia.

Since the incidence of serious effects is quite small this is not a reason to avoid the drug except in cases where there is a known susceptibility to depression but it is important that people taking this understand that it can affect their mood and thought processes so that, should an untoward reaction occur, they will understand it is due to the drug and (1) not despair completely or do anything rash and (2) stop taking it. Without such knowledge a person might easily lose all sense of proportion and be subsumed by the depression.

[groovetank]

Champix worked for me... I had tried a few different methods but this was the only one that really worked. However, it is a very strong drug... I have used Champix twice.. (I started smoking again on holiday...dumb) Both times i have had the most amazing dreams every night... so realistic.. not always nightmares.. but crazy dreams..every night.. I was also very very moody.. I am moody anyway but my girlfriend said i was totally out of order. Suffered some sleeplessness but not bad.. NO SUICIDAL THOUGHTS...

My Dad who was a smoker for 40 years has finally given up using Champix... HE HAD NO SIDE EFFECTS WHATSOEVER... i was blown away.. he is a grumpy bastard anyway.. but he seemed to cheer up! (Now he is the most annoying reformed smoker you have met)

They did not work for a few friends of the family though so

Conclusion - I personally think they are great.. i think they stimulate a lot of brain activity and i guess that some might be bad activity for some people.

I do think that they are not some sort of magic pill so you still have to be ready to give up... Perhaps the people who are having these bad experiences are being pushed into doing something they are not ready/don't want to do...... and that may cause anyone to slide into depression...

Good luck all potential quitters ..

[davenjeip]

I am taking Chantix right now, for the second time. I quit smoking with it, started smoking again a few months later, and have just quit again. Nothing else I did worked for me at all, but this stuff has been amazing.

I do not sleep well while taking it, and I have crazy dreams that feel real like the way a nightmare does. Upon advice of a friend, I started making sure to take my first dose as soon as I woke up and my second exactly 12 hours later, and this has helped my sleeping some. I think having it in your body for a few hours before you sleep lessens the effects, but it might just be the way it works for me.

I have a friend that had to stop taking it because she got very depressed and had suicidal thoughts. Another friend was crazy the whole time he took it. Point is that it seems to work differently for everyone.

I do not worry about how it says it will make you irritable and angry. You are quitting smoking, and I don't know anyone who can do it without feeling that way. Not sure that it's fair that this gets blamed on Chantix.

There are side effects, but it will help you quit smoking. It works differently than other methods, and for some of us it's the best option.

[Sisaketmike]

Guess its one way to quit smoking ! makes u wonder how it can be approved by the FDA with such strong side effects

They are not liars, those who committed suicide stopped smoking.

[surangw]

maybe the "master plan" here is to get them to buy anti depressants also?