Safety advocates seek stronger warnings on Chantix

[TheNutcracker]

Last edited Thu Oct 9, 2014, 02:52 PM - Edit history (1)

Posted: Wednesday, October 8, 2014 10:44 am

Associated Press

WASHINGTON (AP) — Public safety advocates are asking the federal government to strengthen warnings on Pfizer's anti-smoking drug Chantix, even as the drugmaker prepares to argue that a bold-letter warning about psychiatric problems should be removed from its medicine's label.

Five advocacy groups petitioned the Food and Drug Administration on Wednesday to expand Chantix's boxed warning, which currently warns of potential side effects like mood changes, depression, hostility and suicidal behavior. The groups say the label should also include risks of blackouts, convulsions and other problems reported in some patients.

The groups urge the FDA to revisit the boxed warning, first added in 2009, arguing that it "substantially underestimated the psychiatric adverse effects and accident risks of Chantix." They also argue that Chantix should be contraindicated for people working in critical or hazardous occupations, like pilots, air traffic controllers, police and military personnel. The petition notes that the Federal Aviation Administration and the Department of Defense already restrict the use of Chantix.

A spokesman for Pfizer Inc. said the company is reviewing the petition.

The move by safety advocates comes just over a week before the FDA meets publicly to review Chantix's risks. Pfizer has conducted several studies showing no link between its drug and suicidal behavior and the FDA added information from those studies to the drug label last month. Company executives say they plan to use next Thursday's FDA advisory panel meeting to argue that the boxed warning is no longer warranted.

The New York-based company paid more than $275 million last year to settle some 2,500 lawsuits alleging Chantix caused various psychiatric problems, injuries and suicides.

The FDA first began investigating potential side effects with Chantix in 2007, the year after it hit the market.

The drug's labeling tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes. Doctors are advised to weigh the drug's risks against its potential benefit of helping patients quit smoking.

Pfizer's drug works by binding to the same spots in the brain that are activated by nicotine when people smoke. The drug, known chemically as varenicline, blocks nicotine from binding to those spots and prevents the release of "feel-good" brain chemicals that make smoking so addictive.

Chantix had global sales of $648 million last year. That was down about 26 percent from the drug's peak sales of $883 million in 2007.

Pfizer shares slipped 5 cents to $28.74 in morning trading Wednesday. Its shares are down almost 5 percent over the past three months.

http://www.thedailytimes.com/community/safety-advocates-seek-stronger-warnings-on-chantix/article_538493ae-0331-58fe-8fa8-3fa4e4bfd5e0.html

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I must add, I 'had' a beautiful friend, who used this drug several times to quit smoking. It was hard to believe her doctor would prescribe it again, and again, as they say not to use it that way. This most beautiful spirit turned into a psychotic monster, more hostile than anyone I have ever known. Then became hurtful in so many ways, I almost contacted her family. I decided not to. I quit smoking after starting as a kid. It's now been 19 yrs. Not once was I asked how I did it. I even mentioned that to total silence. One thing that is known, is that you must want to quit. No 'medicine' will just do this for you, unless it's Chantix, that actually changes your brain and creates psychotic episodes that I have witnessed. When you use drugs that work in this way, psychotropic drugs, they deposit into your brain, and change the chemistry of the brain. You don't 'pee' them out like other drugs. They stay there. This new behavior was very noticeable, and intolerable. It ended badly. One of the saddest situations that I have ever known.

[TheNutcracker]

1. Please K&R to the greatest - to help remove this awful drug from the market.

And help to save the beautiful people who are addicted, from something worse.

[Oktober]

5. I gotta say that it worked for me...

Took all my joy out of Copenhagen and that was that...

[central scrutinizer]

10. worked for mrs. central scrutinizer

a smoker from ages 14-50, now free for several years

[WillyT]

2. K & R !!!

Thank you for this...

[2naSalit]

3. K&R

[littlewolf]

4. I am very sorry for you and your friend.

I never smoked in my life, both parents did, I watched it kill them both.
Mom - a Stroke and 2 Heart attacks that killed her.
Dad - Emphysema he had a "bubbler" that pumped O2 to him, he was on a tether. he could go from his bed to his chair and watch TV.
if he left the house he had pony O2 bottles.
he finally died of O2 deprivation.

Me - 2nd hand smoke Asthma and Bronchitis both from home
and the military.
so I have some pretty bad breathing problems. but all in all I am doing OK.

[TheNutcracker]

16. So sorry for you as well. Another friend never smoked and has one lung cuz 2nd hand smoke as child

[calimary]

6. Okay, NO doctor here, so my opinions should be regarded accordingly. However,

it just strikes me as a big red flag when watching these commercials about all these drugs, whether it's for non-smoking or flaccid penises or depression or "COPD" or whatever cutesy, coy little nicknames (heard a new one just yesterday -"Hep-C" - file that one away next to "Low-T" and all the "hip" little abbreviations and nicknames and 140-character approaches, I suppose) we have these days that allow us to avoid naming the actual names of the disease/syndrome/malady/whatever-the-hell.

And that's ANNOYING AS HELL, just by itself.

But what else bothers me is - if you'll notice during any one of these commercials, a comparatively long portion of the voice track involves reading the fine print, the contraindications, the "don't take this if you have blah, and blah-blah, and blah-blah-blah, or blah-blah-blah-blah, or colon-blah-blah-blah, or ailment A-B-or-C-blah-blah-blah" - and finally even to the "may-cause-death-blah-blah-blah." That makes me wonder - um... gee, um... should we REALLY be advertising this? Should we REALLY be pushing this particular medication that "may cause death..." ?

It makes me wonder what might happen if the pharmaceutical conglomerates redirected all those billions of dollars in advertising money getting you to "ask your doctor if blah-blah-blah is RIGHT for YOU!" into MORE RESEARCH so that maybe we'd be a little more sure of some of these drugs? Maybe we'd come up with a few safer options? If almost half the commercial - featuring a fast-reading voice-over announcer trying to squeeze a LOT of complicated copy into just a little window of time - cautions about the hazards of taking such a drug, WHY is there such an aggressive push to get people to take it?

I would rather they splurge all that ad-buying money into research and development of more and better, more effective, and possibly even more AFFORDABLE meds.

Again, not a doctor here. Not even married to one. So my views on this issue are probably already compromised to some extent. And undoubtedly naive. Deep down, I know what the answer is. Cuz they're in it for the money - just more corporate vultures looking to exploit the large available pool of gullible and/or desperate consumers with health challenges. But that's my mental go-to, every time I see one of those commercials.

[arikara]

11. I think most of the so-called research done by drug companies

is market research.

I read a good article about how they do the testing now, its not here and its not necessarily on people who have the conditions the drug is meant for. Scary stuff. With all his health conditions, I won't let my Mr take a pill unless its been on the market for at least 7 years, and I read up on it first to make sure there are no black box warnings. The older the med, the more tried and true. That's not to say there still aren't problems with them. Now they are making the generics for Canada in India which was just caught adulterating some of them with banned substances, and apparently Health Canada can't or won't do a thing about it.


http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101

[HERVEPA]

7. Would be useful if the names of the advocacy groups were given in the article.

No way to know whether they are reputable or woo folks from the article.

[TheNutcracker]

17. Many links on google for this story. Maybe they are in others?

And I witnessed it for myself!

[NaturalHigh]

8. I've heard horror stories about Chantix.

In all fairness, my mother-in-law stopped smoking with Chantix, but she hated the way it made her feel.

[TheNutcracker]

13. Not everyone reacts the same to any medicine. I did witness this, with this person. AWFUL!

[truebrit71]

9. Don't know about the psychiatric problems it may cause, but it gave me some REALLY vivid dreams...

...oh...and it didn't do a damned bit of good helping me quit smoking...that i did by myself, cold turkey, 4 1/2 years ago...

[TheNutcracker]

14. Congratulations to you!!! It's the best thing, one of the hardest a person can do!

It PROVES you are in total control of yourself if you can quit!

Nicotine has properties like heroin. Soooo addictive.

[truebrit71]

22. Yup. It was my eighty-millionth time at quitting...

...and it has worked so well this time that I am now the archetypal disgusted ex-smoker...

[Tikki]

25. Honestly, I believe Cold Turkey is the best and most complete way to quit smoking..

My son used the gum, it worked for him and I quit along side of him by going Cold Turkey.

We both have been nonsmokers for over 11 years now.

The money savings is what really did it for me...that was my #1 motive.


Tikki

[arcane1]

28. Every month, I calculate how much money I "saved" by not buying cigs.

It adds up FAST!!!!

[GeorgeGist]

32. I tried everything without success ...

then I tried Chantix and it was easy. But that's just me.

[Tikki]

33. My son used the gum and that did the trick for him...you are correct...WHATEVER it takes...

The goal is the same...no more buying cigarettes and no more smoking.


Tikki

[Treant]

12. I had a terrible reaction

Constant moderate to severe headache, constant nausea, and it set off a depressive episode that took three months to counteract and fix.

Fortunately, my doctor warned me about that last bit so I knew what was happening, discontinued treatment, and called him immediately. We rebalanced my anti-depressant medications and things worked out.

I was lucky...and had a knowledgeable doctor.

[TheNutcracker]

15. Are you smoke free? I hope so after all you went through...

[Treant]

29. The Chantix failed

The electronic vaporizer worked. So yep, 2+ years smoke free, nicotine levels fading down to practically nothing at this point.

[Uben]

18. Got it 2 yrs ago

...but, its still sitting in the cabinet. After reading the potential side effects and reading some personal testimony on the product, I chose not to use it. I was a good candidate for depression at the time, and chose to be safe rather than sorry.

[a kennedy]

19. This is so true......

One thing that is known, is that you must want to quit. I did do Wellbutrin to quit.....this was in 2005. I've been 9 years free of tobacco, just couldn't afford the habit anymore. Best, AND THE HARDEST THING I ever did. But am so happy I did.

[broiles]

20. After one week, I was really ditzy and had trouble making decisions.

Call my doc and he said stop immediately.

[tridim]

21. It was the last pharmaceutical drug I ever put in my body.

I am a very calm person and it immediately changed me into a psychotic road-raging jerk. I was actually screaming at drivers on the highway from my window. I stopped taking it immediately.

Sorry about your friend, I totally understand.

[BobbyBoring]

23. That's what it did to me as well

That and the fucking nightmares! Had to quit after 2 weeks.

[forthemiddle]

24. It worked for me

After multiple tries at quitting Chantix was the only thing that worked for me. I smoked from age 13 to age 43.
It's been more than three years since I quit, and I thank Chantix for that.
In the past nine months, both of my parents have died from smoking related diseases. Dad just 3 weeks ago. To watch both of my parents spend the last weeks of their lives unable to breath, literally has been Hell on Earth. So while I am sympathetic to those that have the rare side effects, I also realize that others lives will be saved because of this med.

[Tracer]

26. My daughter used Chantix a few years ago, trying to quit.

It made her weepy, angry, depressed to the point where her doctor prescribed Zoloft.

When I heard about that, I demanded that she quit BOTH drugs. It took her weeks to get back to normal.

Now she's trying it again, and so far she hasn't had any bad reactions -- maybe a little more emotional than usual.

The problem is that Blue Cross will only allow 2 months worth of Chantix. After that, you are on your own to the tune of $300 per month.

[arcane1]

27. You couldn't PAY me enough to take this awful drug.

I'm 10 months smoke-free without it anyway!

[TheNutcracker]

30. I was told it was very expensive as well

Criminal I tell you!

[TheNutcracker]

31. K&R and get this crap taken off the market