Suicidal Thoughts Linked To Anti-Smoking Drug Chantix Says FDA

Suicidal Thoughts Linked To Anti-Smoking Drug Chantix Says FDA

www.medicalnewstoday.com

The US Food and Drug Administration (FDA) has issued what the agency terms an "early communication" about a potential, but yet to be confirmed, safety issue with Pfizer's smoking cessation drug Chantix, where a number of postmarketing cases have reported patients on Chantix experiencing suicidal thoughts and related erratic behaviour.

The information on the cases involved was given to the FDA by the drug maker Pfizer Inc, as part of ongoing post marketing safety monitoring.

(visit the link for the full news article)


Related News Links:
live.psu.edu
en.wikipedia.org
www.fda.gov

[edit on 23-11-2007 by anhinga]

As you all may already know, I am not for anything the FDA usually does, but this drug seems to be bad news. Here's from one of the 'additional links' about some of the other site effects:

* Nausea * Headache * Vomiting * Flatulence
* Insomnia * Aggressive and Erratic Behavior * Drowsiness
* Abnormal dreams * Dysgeusia (alteration in taste)

In November 2007, the FDA announced it had received post-marketing reports that patients using Chantix for smoking cessation had experienced several serious symptoms, including suicidal ideation and occasional suicidal behavior, erratic behavior, and drowsiness. It is unknown whether the psychiatric symptoms are related to the drug or to nicotine withdrawal symptoms, although not all patients had stopped smoking. The FDA recommended that health care professionals and patients watch for behavioral and mood changes.[5]

There are known herbal remedies for smoking cessation for those interested, between this drug and the patch, you're asking for trouble.

www.medicalnewstoday.com
(visit the link for the full news article)


[edit on 23-11-2007 by anhinga]

Smoking is a form of suicide to begin with but I sure don't like that list of side effects.

You'll feel like crap, start puking, and fart like an old granny. Then if you don't kill someone you'll fall asleep and have weird dreams.:shk:

It sounds like the cure is worse than the affliction.
At least Pfizer is taking a proactive approach in releasing this information to the FDA before they end up in court trying to justify endangering the public.

My wife and I both gave up smoking using Chantix (it's called Champix here in the U.K). The only side affect I got was nearly throwing up about twenty minutes after every time I took one, my wife was the same except her nausea was lesser, the nausea passes after 5-10 mins. In the Champix box you get the user instructions and a list of side affects, those side affects listed above are less than half of what's listed in the leaflet, quite scary to see.

reply to post by Corum


Exactly right, here's a shortlist from an Rx site:

Following is a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

EYE DISORDERS. Infrequent: Conjunctivitis, Dry eye, Eye irritation, Vision blurred, Visual disturbance, Eye pain.

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS. Frequent: Chest pain, Influenza like illness, Edema, Thirst. Infrequent: Chest discomfort, Chills, Pyrexia.

INVESTIGATIONS. Frequent: Liver function test abnormal, Weight increased. Infrequent: Electrocardiogram abnormal, Muscle enzyme increased, Urine analysis abnormal.

NERVOUS SYSTEM DISORDERS. Frequent: Disturbance in attention, Dizziness, Sensory disturbance. Infrequent: Amnesia, Migraine, Parosmia...

REPRODUCTIVE SYSTEM AND BREAST DISORDERS. Frequent: Menstrual disorder. Infrequent: Erectile dysfunction. Rare: Sexual dysfunction.

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS. Frequent: Epistaxis, Respiratory disorders. Infrequent: Asthma. Rare: Pleurisy, Pulmonary embolism.

www.rxlist.com...

Just how toxic is this stuff? I'm looking, more later . . . afraid of the mice results studies. . . .

[edit on 23-11-2007 by anhinga]

...got 'em, yet again, should you of seen any of my recent posts in the cancer threads, you'll A. know I've had it w/ the FDA and B. pointed out recent (2002) studies that have confirmed that humans and mice share almost the exact number of genes, w/ 80% of the same diseases. So, right, here's the data:

Carcinogenesis
Carcinogenesis was not demonstrated in mice receiving varenicline up to 2 years. In male rats, brown fat tumors developed at an increased incidence when given doses 23-67 times the maximum human dose. This was not seen in female rats. The clinical relevance in humans is unknown.

Shameless, from their own research, 20 page pdf:

www.pbm.va.gov...

I know the dosage is much higher, but the side effects already are bad enough, plus I don't trust their version of the truth, this could of been a significant number of dosages less, but sure, here I'm totally speculating...

...I found the scientific name of this, here's another pdf, it's really toxic in animals at high dosages and here's some results of a human group test:

Higher appetite: 47%
Weight gain: 21%
Irritability: 36%
Dry mouth & throat: 35%
Sleep disturbance:

Chantix changed my life.

I had very bad experiences with this drug. I don't have time right now to tell some the side affects I experienced, but I will come back to this thread tomorrow and let you know.

It's really amazing to me that it's a miracle drug for some, but can lead to insanity or worse for others and nobody bothers to tell you.

I will never again take a drug that affects my brain in any way.

Whatever happened to self-discipline? You can quit without any mind altering drugs, or nicotine patches. I did, and I turned out okay. That said, the first week was terrible.

I must say, a friend of mine is taking Chantix. He has had several side effects including depression, anxiousness, inability to sleep, and when he does sleep, crazy dream patterns. Also night sweats and thirst. Quitting any addiction can be done through all will power, you just have to be driven and motivated to quit.
My friend has stopped smoking but at what other costs is what I am wondering.

reply to post by palehorse23


...with those side effects? No way, the costs outweigh the smoking dangers since there's better ways to quit. Gradual, cold turkey, the 'tea tree oil' toothpicks/extracts are meant for quitting and this herb.

Lobelia. It's an odd herb, dangerous in high doses, actually anything over a slight amount. I'm surprised the Wiki page doesn't have more warnings, but it's good they mention it at all... I've heard from friends, this produces a taste that makes the taste of cigarettes awful, should you use the 'loose herbs' for making teas. They say it works! Hey, that's a cheap method of quitting!

en.wikipedia.org...

[edit on 23-11-2007 by anhinga]

God, is there any end to these drugs that are coming out on the market these days, that have potentially terrible side effects? Even if you don't get immediate side effects, what happens with long term use?

Why do people fight tooth and nail to defend the drug companies? Because someone here at ATS will undoubtedly defend the drug companies.

The prescriber states, "Here, we'll poison you and call it a cure." The patient sais, "Sure, I'd like to try some of that. Sounds like a wonderful thing." It's insanity. Actually, that's not how it's really communicated toward you. I don't think it's made abundantly "clear" what could happen to you. As far as the commercials are concerned, the bad side effects are glossed over with a very thick "veneer" of all the happiness and joy that will come from this drugs use, while a happy and calm voice tells you terrible side effects as if they are nothing to be concerned about. "Nothing to worry about fellow, probably not going to hurt you," says the commercial.

Seriously, I have actually felt a sense of "calm and reassurance" watching these commercials, even though they just listed some very terrible side effects. You kind of think, "well, this isn't so bad." But the rational side of me kicks in at some point.

I think these commercials are there to program you, and they get in your mind. Which is what commercials kind of tend to try and do anyway. But this is quite sleezy with the drugs. This is sort of like having someone dressed and acting as a sweet little ol' lady, giving away yummy cookies and milk. But the cookies and milk are laced with a toxic substance.

Troy

DON'T YOU GET IT? THE FDA IS TRYING TO SHOOT DOWN THIS DRUG BECAUSE IT CAN NOT MAKE MONEY OFF IT. MOST DRUGS APPROVED BY THE FDA ALSO CAUSE SUICIDAL THOUGHTS. IF THIS DRUG WORKS THE GOVERNMENT WILL LOOSE # LOADS OF MONEY FROM PEOPLE QUITING SMOKING. # LOADS OF DEATH MONEY.

[edit on 24-11-2007 by St.Joseph]

Wow... Phewee... Taking drugs? They call it free will. Just because someone produces a drug doesn't mean you have t take it.

Herein lies the mentality that says... I'm an adult, just because I can, doesn't mean I have to...

These posts seem to want to blame the drug companies (I'm not defending them, but put blame where blame is due). You don't have to take the medication just becuase it is available... Then, if it creates some or any of the possible advertised symptoms,you blame the creators, who advertise those possible side effects, as children of Satan...

You can not have it both ways all the time.

Chantix is not new... It is an available by prescription only tranquilizer, tatamount to a narcotic, that has the side effect of helping up to 44% of the people who take a 3 month course to quit smoking. It was not created to be a stop smoking pill.

You folks who sat around and got nausea, gas, vomiting, or what have you, probalby didn't call the hot line or talk to anyone in their support program, did you?

Man... I hate the mentality that seems to permeate this board, and society in general today. That mentality that is so quick to blame everyone and everything else...

Some discussion veering towards 'supply and demand' in my opinion... I totally agree w/ the last few postings on certain terms. Yeah, the commercials make taking said drugs like 'a better life' w/ people 'happy' and active, but for me, when they goto 'rapid talk' to get the side effects listed -- where's the sardonic response of, "no thanks." (?)

Point being, like sigung86 mentions, people are deciding to take them, when some pretty vicious side effects are obviously brought to their attention numerous times. Sure, the 'doctor' prescribing the (usually) poison dosages is getting 'kickbacks' from the pharm companies (seen it first hand from working for one, as in, a co.), so they usually will "look the other way" when some controversial tests arise and prescribe 'sedatives' or 'sleeping pills' or 'anti-anxiety' to calm patients later.

It's a special-interest industry that the American consumer is helping to keep afloat by continuing to 'take drugs' at their expense/health in the long run. And many times, in the 'short run' since the aforementioned 'side effects' should be considered damaging.



[edit on 24-11-2007 by anhinga]

I quite smoking with Chantix. I had no problems at all. I'd do it agian without hesitation. You are only on Chantix for a few weeks. They gave me complete test results with the starter package and the risks are probably lower than Tylenol for a bad side effect.

People need to consider the risks and make individual decisions. If a handful of people out of millions have a side effect I don't see how drugs should be pulled from the market. Look at Penicillin. Deadly to some but has saved many millions of lives.

Originally posted by anhinga
reply to post by palehorse23

 

...with those side effects? No way, the costs outweigh the smoking dangers since there's better ways to quit. Gradual, cold turkey, the 'tea tree oil' toothpicks/extracts are meant for quitting and this herb.

[edit on 23-11-2007 by anhinga]

You are grossly exaggerating the dangers. None of the other methods worked for me and this one did. To equate the dangers of smoking with a few weeks of this drug is about as intellectually dishonest as a person can get. I still may die from the smoking I already did, but I will suffer zero effects from taking Chantix for a few weeks. For me it worked. I think Medicine should be left up to MD's and others who give advice are hardly qualified. In fact the Pharmaceutical Companies are trying to kill you bunch are murderers themselves if they influence uniformed people into believing them.

There were no effects whatsoever and we all know that just reading the warning causes some people to have psychosomatic symptoms. I'd bet half the reported side effects are just that. Take a look at a double blind study some time. The number of psychosomatic issues are nearly as large as the real ones.
______________________
To others: Talk to your doctor. Don't get medical advice on ATS. It's just dumb to get advice from strangers on the Internet instead of from a qualified MD.

Originally posted by anxietydisorder

You'll feel like crap, start puking, and fart like an old granny. Then if you don't kill someone you'll fall asleep and have weird dreams.:shk:

I had none of those effects. I had no effects at all other than it was easy to quite.

Your name is Anxietydisorder?

Higher appetite: 47%
Weight gain: 21%
Irritability: 36%
Dry mouth & throat: 35%
Sleep disturbance:

Sorry, the drug companies don't get off that easy, just because "some" people were apparently helped. No pat on the back here. I'm having a hard time trusting them with my health, because of things psychiatric medicine causing problems for family members. I only want pharmacy drugs when it's necessary, not for continued habitual use. (I know that the drug in question may not be a long term thing but....) If I'm going into surgery, yeah, I want numbing medication.

In 15+ years I have only been to the doctor a small amount of times, counting some dental work. I have taken so little medication in that time, it's not worth counting. I take care of my illnesses naturally, and in some cases I've recovered quicker than those who tried otherwise. I believe I spend a lot less time being ill than my family and friends.

I don't get a lot of respect from some people because I didn't seat myself behind massive text books in the pursuit of a doctors degree. Me and dad butt heads on this a lot. Nope, I'm not a doctor, nor do I necessarily want to be one. Unless, it included an honest look at nutrition and an honest look at natural and safe therapies in the indoctrination process. I feel the education system can have a tendency to "omit" such therapies. It is a shame, I know there is hope beyond typical drug and "turkey carving" therapies. Not to say that "all" surgery is unwarranted or anything like that. But with things like "gastric bypass surgery" I think some doctors are a bit "trigger happy" when it comes to knives.

Couldn't the doctors have simply made some dietary changes and brought about excellent results without messing with the inner working of the digestive system? This is maybe a bit off topic, but it's not much different than prescribing overly powerful and potentially poisonous drugs. Gastric bypass is "extreme;" you do not digest food like you used to. My understanding of the theory is that you don't take in as much calories and stuff from the food, so you lose weight. Hello, wouldn't it be much safer to just cut the portions, instead of potentially killing the person? And some drugs are extreme in a similar fashion.

This is not to say I know "all" on the subject of health; I still have more to learn. I do sometimes just try and give hints instead of giving flat out health "advice." I advise people to do their research, I make no claims of being an expert.

And, honestly, sometimes, a doctor is needed for assistance. Let's be real, I want a "doctor" to set my broken bone, should I break one. Or put my finger back on, if I slice it off. I'm not going to the health food store to ask for advice on setting bones.

Even considering all I've said, "do not blindly trust everything you read on the internet." You need to be smart and do some careful research.

I've tried to make it clear that I'm not against those who have entered the medical field, with the intention of helping others, times before. I know some folks work their asses off to try and save lives and do what they know to do, to help people. Miracles have happened for sure in places like the ER and OR! But, some folks, for whatever reason, only believe what the texts and so-called experts say. They completely trust the source, and wouldn't dare question this "trusted source," that educates our medical workers. You pay $50,000 for this education, then everything "must" be true, right?

Sleepy time, good night.

Troy

[edit on 25-11-2007 by cybertroy]