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Old 05-21-2008, 04:50 PM   #1
scotty
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Smoked: Chantix May Cause Many Serious Problems

http://www.pharmalot.com/2008/05/smo...ms/#more-13751


Smoked: Chantix May Cause Many Serious Problems

May 21st, 2008 6:04 pm By Ed Silverman

The smoking-cessation drug has generated headlines over links to suicide, but the Pfizer pill is now being tied to other serious adverse events reported to the FDA, according to a study published in Drug & Therapeutics Bulletin. And the authors urge the FDA and Pfizer to conduct epidemiological studies to assess further risks and to issue new warnings. Wall Street, meanwhile, is worried the study will cause Chantix sales to go up in smoke.

Chantix is suspected of causing a “wide spectrum of injuries,” including serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetess, psychosis, aggression and suicide, the authors write.

In last year’s fourth quarter, Chantix accounted for 988 serious injuries in the US reported to the FDA, more than any other individual drug in this time period. By comparison, the FDA received a median of five reports of serious injury for 769 different drugs. Only 35 drugs accounted for 100 or more reports, according to the study, which was conducted by the Institute for Safe Medication Practices.

The FDA recently issued a Public Health Advisory noting suicidal ideation, and attempted and completed suicide, but there were no numbers of reported psychiatric events among treated smokers, the authors note. From May 2006 through December 2007, the FDA received 227 reports of suicidal acts, thoughts or behaviors, 397 cases of possible psychosis and 525 reports of hostility or aggression. These included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination. The categories weren’t mutually exclusive.

However, the adverse event reports describe other kinds of serious harm for which no warnings now exist, either from the FDA or Pfizer. These include accidents and injuries; vision disturbance; heart rhythm disturbances; seizures and abnormal muscle spasms or movements; moderate to severe skin reactions and diabetes, according to the authors. (Here is the summary).

“We have immediate safety concerns (about people taking Chantix while) operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury.” They also cite nuclear power reactors, high-rise construction cranes or life-sustaining medical devices.


“The extent to which Chantix has already contributed to accidental death and injury has not yet been investigated because these adverse effects had not been previously reported,” they write. “We urge the FDA and the manufacturer to provide warnings to doctors and patients for those adverse effects that can be adequately documented through existing data, and to undertake on a priority basis epidemiological studies or other research to assess other potential risks.”

A Pfizer spokesman sends us this statement: “We closely monitor post-marketing reports of adverse events that we receive for our medicines as part of our commitment to accurately reflect each product’s efficacy and safety profile in labeling. Pfizer reports all such events to the FDA and other regulatory agencies and communicates safety information to physicians and patients in a variety of ways including through labeling and educational materials.

“Based on Pfizer and the FDA’s continuous review of all available safety information, including adverse event reports received to date, the current Chantix label accurately reflects the product’s efficacy and safety profile. For example, the current label includes safety information pertaining to certain serious neuropsychiatric symptoms, as well as driving and operating machinery.

“We understand that the Institute for Safe Medication Practices report was based solely on a review of post-marketing adverse event reporting data. It is important to understand the limitations of spontaneous adverse event reporting. Often these reports lack sufficient medical information and/or have confounding factors that prevent a meaningful assessment of causality.”


Meanwhile, Sid Wolfe of Public Citizen also issued a statement saying the large number of adverse reactions “adds new urgency to our previous safety concerns about Chantix. It also highlights the dangerous inadequacy of the response of Pfizer and the FDA to the rapidly increasing number of serious, life-threatening adverse events seen with this drug.”

He goes on to reiterate concerns he expressed last year in which he cited an “inadequate amount of information” about psychiatric adverse events that occurred in the randomized trials preceding Chantix approval. In one of the studies, 6.8 percent of patients using Chantix had psychiatric adverse events as opposed to only 2.4 percent of those given a placebo, Wolfe says.

The study prompted Tim Anderson, an analyst at Sanford Bernstein, to issue this note: “In the current safety-conscious environment, where will this lead to next? With the recently updated Chantix label (includes a bolded warning, but not a Black Box warning) it is unclear whether additional regulatory action will be taken.

“What is clearer, however, is that consensus forecasts for Chantix appear to be too high given current prescription trends. The most recent weekly prescription figures show that new prescriptions for Chantix are declining by nearly 30 percent year-over-year. This compares to consensus forecasts that have Chantix growing in 2008 and beyond. On the current trajectory, consensus sales forecasts for Chantix could be too high by as much as $500 million to $1 billion by 2012.

“Our estimates have been too high as well – given prescription trends we are lowering our sales forecasts for the product. Our 2008 worldwide Chantix sales forecast drops from $1.14 billion to $909 million; our 2012 forecast drops from $1.65 billion to $720 million.”
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Old 05-21-2008, 06:32 PM   #2
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Re: Smoked: Chantix May Cause Many Serious Problems

Thanks Laurie!

Glad to see any report coming out the adverse affects of this drug. Besides the stuff we dealt with or deal with at home, Larry has had many accidents at work this year. This such a bad drug. Taken for so short of a time and causing such horrible damage. Many people are suffering from it and I can't wait to see that 30 percent go to 100 percent!

Lilly
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1 .5 Xanax a day for one month. C/T.

Same year, 3 .5 mil Xanax a day, 4 by the end. Pooped out on me. 1 1/2 years on the drug. Doctors taper. Very bad w/d.

9 months later took 10 mg Paxil and my Xanax w/d dissapeared. On 20 mg by end. Pooped out on me. C/T then restarted it again after 3 days and big blow up. 6 months taper, never feeling much better. 2 1/2 years solid w/d then sporadic stuff for 5 years.

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Old 05-21-2008, 07:59 PM   #3
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Re: Smoked: Chantix May Cause Many Serious Problems

Those highlighted paragraphs say it all. We're just rats in a maze.
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Am I better? I would say I am now traumatized by the withdrawal. The depression is constant and deep, but not suicidal. Can sleep, but now always tired.
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Old 05-22-2008, 06:59 AM   #4
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Re: Smoked: Chantix May Cause Many Serious Problems

You know that there have got to be people out there that are on Chantix and an SSRI. Can you imagine how they must be acting ?
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Old 05-22-2008, 07:22 AM   #5
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Re: Smoked: Chantix May Cause Many Serious Problems

Here is one of them! I'm on Chantix and Paxil! Stared today to cut dosage of Paxil from 30mg to 20mg. Have no idea what Chantix is doing to me, other than making cigs (and some foods) taste bad. We're turning into a society that wants immediate results on everything, so we take a pill.
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Old 05-22-2008, 08:19 AM   #6
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Re: Smoked: Chantix May Cause Many Serious Problems

Ill keep smoking for now, thank you.
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Old 05-22-2008, 02:38 PM   #7
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Re: Smoked: Chantix May Cause Many Serious Problems

I heard this on the news several times yesterday. I am really happy that the word is getting out about this drug…….....but, I have to admit that I am more than a bit perturbed that doctors and the FDA appear to be taking Chantix patient’s complaints more seriously than anti-depressant users.

I read that more Chantix ADR complaints were reported than any other drug on the market. Hmmmm……….I find it really hard to believe that people are actually suffering more from Chantix than SSRI’s and I have a feeling this is due to doctors brushing off ssri user’s complaints.

Sorry……..I’m a bit bitter. I tried educating my doctor as to what happened to me but she blew me off saying my system was just really sensitive and oh, btw, why don’t you try Cymbalta. ARGH!!! No wonder doctors don’t know about the side effects of these drugs………..they IGNORE their patients!

lov
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Resolved:
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ANHEDONIA
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Old 05-22-2008, 03:15 PM   #8
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Re: Smoked: Chantix May Cause Many Serious Problems

I've read of lots of people who were on ssri's first. I've also read lots that have gone onto them after. And Benzo's and other drugs. I think it is getting so much attention, because it is causing very bad effects right away for the people taking them and they are reporting them there doctors right away. Maybe they are taken more seriously than people getting on ssri's. You know the mental stuff verses smoking cessation. I've read lots of reports of people that have died or are dying to from physical stuff.

Hey joe! Welcome to PP. If you run a search here on Chantix, I have a huge thread on it about my husbands use and other threads with lots information on them if you are interested. I'm a bit worried about you, w/d from Paxil and on Chantix!

Lilly
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1 .5 Xanax a day for one month. C/T.

Same year, 3 .5 mil Xanax a day, 4 by the end. Pooped out on me. 1 1/2 years on the drug. Doctors taper. Very bad w/d.

9 months later took 10 mg Paxil and my Xanax w/d dissapeared. On 20 mg by end. Pooped out on me. C/T then restarted it again after 3 days and big blow up. 6 months taper, never feeling much better. 2 1/2 years solid w/d then sporadic stuff for 5 years.

Completely recovered!
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Old 05-22-2008, 03:28 PM   #9
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Re: Smoked: Chantix May Cause Many Serious Problems

Quote:
Maybe they are taken more seriously than people getting on ssri's. You know the mental stuff verses smoking cessation.
You hit the nail on its head Lilly!
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Old 05-22-2008, 03:32 PM   #10
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Re: Smoked: Chantix May Cause Many Serious Problems

In Canada this drug's name is: Champix. I'm just letting everyone (outside the USA) know who reads this thread that it's the same drug.
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Old 05-22-2008, 04:27 PM   #11
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Re: Smoked: Chantix May Cause Many Serious Problems

The FAA just banned it.
http://www.baltimoresun.com/news/nat...,7577096.story.

Lilly
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1 .5 Xanax a day for one month. C/T.

Same year, 3 .5 mil Xanax a day, 4 by the end. Pooped out on me. 1 1/2 years on the drug. Doctors taper. Very bad w/d.

9 months later took 10 mg Paxil and my Xanax w/d dissapeared. On 20 mg by end. Pooped out on me. C/T then restarted it again after 3 days and big blow up. 6 months taper, never feeling much better. 2 1/2 years solid w/d then sporadic stuff for 5 years.

Completely recovered!
Drug free since June 2001.
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Old 05-22-2008, 04:33 PM   #12
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Re: Smoked: Chantix May Cause Many Serious Problems

Just for pilots.
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Old 05-22-2008, 05:07 PM   #13
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Re: Smoked: Chantix May Cause Many Serious Problems

I'm sure this is just the start of it. Wondering what incidents happened to make the FAA look at this got me thinking about taking drives with Larry back then. First he started hitting curbs and running over easements. He's always been a perfect driver. Then any drive at all with him would terrify me. I'd sit there looking next to me praying we were not going to swipe the cars parked on my side of the road. We would be so close to them! He would yell at me if I said anything. I stopped riding with him and at one point I took my car keys away from when he told me was driving my car at 130 miles per hour to work.

Laurie feel free to use any part of my story I've told you about when speaking about Chantix okay?

Lilly
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1 .5 Xanax a day for one month. C/T.

Same year, 3 .5 mil Xanax a day, 4 by the end. Pooped out on me. 1 1/2 years on the drug. Doctors taper. Very bad w/d.

9 months later took 10 mg Paxil and my Xanax w/d dissapeared. On 20 mg by end. Pooped out on me. C/T then restarted it again after 3 days and big blow up. 6 months taper, never feeling much better. 2 1/2 years solid w/d then sporadic stuff for 5 years.

Completely recovered!
Drug free since June 2001.
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Old 05-22-2008, 05:36 PM   #14
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Re: Smoked: Chantix May Cause Many Serious Problems

Quote:
Originally Posted by Lilly View Post

Laurie feel free to use any part of my story I've told you about when speaking about Chantix okay?

Lilly
Thanks Lilly....you know I will. I'm heading to Washington again in the early part of June
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Old 05-22-2008, 05:52 PM   #15
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Re: Smoked: Chantix May Cause Many Serious Problems

I'll be watching!

Lilly
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1 .5 Xanax a day for one month. C/T.

Same year, 3 .5 mil Xanax a day, 4 by the end. Pooped out on me. 1 1/2 years on the drug. Doctors taper. Very bad w/d.

9 months later took 10 mg Paxil and my Xanax w/d dissapeared. On 20 mg by end. Pooped out on me. C/T then restarted it again after 3 days and big blow up. 6 months taper, never feeling much better. 2 1/2 years solid w/d then sporadic stuff for 5 years.

Completely recovered!
Drug free since June 2001.
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Old 05-23-2008, 09:30 AM   #16
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Re: Smoked: Chantix May Cause Many Serious Problems

Now it's banned for truck drivers! But it's OK for regular people driving????

http://www.pharmalot.com/2008/05/kee...le-on-chantix/

Keep On Truckin’… But Not While On Chantix
May 23rd, 2008 10:33 am By Ed Silverman
First, we’re told we can’t fly our planes if we’re also using Chantix to quit smoking. Now, we can’t drive our rigs, either. The Federal Motor Carrier Safety Administration has issued a warning that advises medical examiners “to not qualify anyone currently using this medication for commercial motor vehicle licenses,” according to The Wall Street Journal.

The move follows a study by the Institute of Safe Medication Practices that found a host of side effects linked to Pfizer’s quit-smoking pill - serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetess, psychosis, aggression and suicide. The FMCSA, by the way, oversees interstate trucking and bus activity.

In all the study, linked Chantix to nearly 1,000 serious adverse events. Just hours after the study was released two days ago, the Federal Aviation Administration banned the drug for pilots and air traffic controllers. So far, though, the FDA, which previously issued health advisories about psychiatric side effects, such as suicide, hasn’t taken any additional action.
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Old 05-23-2008, 11:48 AM   #17
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Re: Smoked: Chantix May Cause Many Serious Problems

Quote:
Originally Posted by scotty View Post
Now it's banned for truck drivers! But it's OK for regular people driving????
The Federal Administration and the Federal Motor Carrier Administration seem to care a LOT more about their people than the FDA does for the public in general.

Just wondering what Pharma lobbying was/is going on at the FDA.

Yeah, regular people don't get into accidents.
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Old 05-23-2008, 01:21 PM   #18
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Re: Smoked: Chantix May Cause Many Serious Problems

Below is a link that I found on PP about nicotinic receptors and antidepressants. My guess is that Chantix in some way or another is linked to the same pathways.

http://www.paxilprogress.org/forums/...ighlight=elisa
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On A/D's since 1995, switching due to side-effects on 30 different brands of TCA's, SSRI's, SNRI's, Antipsychotics, Benzo's & Imovane. 6 ECT's. Tapering from 225 mg Effexor XR May 17, 2004. (Equiv. to 60 mg Paxil) Last taper Effexor XR Jan 17, 2006 down to ZERO. Currently protracted withdrawal. Sept 2006: 25 mg Doxepin. March 13/09: 10 mg Desipramine
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Old 05-23-2008, 01:48 PM   #19
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Re: Smoked: Chantix May Cause Many Serious Problems

Wow! This is moving so fast!!! I have a feeling this drug is going down the tubes thank god!

And Elisa thanks, I'm going to check that link out later!
Lilly
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1 .5 Xanax a day for one month. C/T.

Same year, 3 .5 mil Xanax a day, 4 by the end. Pooped out on me. 1 1/2 years on the drug. Doctors taper. Very bad w/d.

9 months later took 10 mg Paxil and my Xanax w/d dissapeared. On 20 mg by end. Pooped out on me. C/T then restarted it again after 3 days and big blow up. 6 months taper, never feeling much better. 2 1/2 years solid w/d then sporadic stuff for 5 years.

Completely recovered!
Drug free since June 2001.
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