***** FDA Issues Public Health Advisory on Chantix

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html

As the agency's review of the adverse event reports proceeds, it appears
increasingly likely that there may be an association between Chantix and
serious neuropsychiatric symptoms.

As a result, FDA has requested that Pfizer, the manufacturer of Chantix,
elevate the prominence of this safety information to the warnings and
precautions section of the Chantix prescribing information, or labeling.




http://www.fda.gov/cder/drug/infopag...ne/default.htm

FDA ALERT [2/1/2008]: FDA is issuing this Alert to highlight important
revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing
information for Chantix regarding serious neuropsychiatric symptoms.

Serious neuropsychiatric symptoms have occurred in patients taking Chantix.
These symptoms include changes in behavior, agitation, depressed mood,
suicidal ideation, and attempted and completed suicide.

While some patients may have experienced these types of symptoms and events
as a result of nicotine withdrawal, some patients taking Chantix who
experienced serious neuropsychiatric symptoms and events had not yet
discontinued smoking. In most cases, neuropsychiatric symptoms developed
during Chantix treatment, but in others, symptoms developed following
withdrawal of Chantix therapy.

FDA first informed the public about the possibility of serious
neuropsychiatric symptoms in the November 20, 2007 FDA Early Communication
About an Ongoing Safety Review. At that time, information about serious
neuropsychiatric symptoms in patients taking Chantix was added to the
POST-MARKETING EXPERIENCE section of the prescribing information. As FDA's
review of the issue has progressed, it appears increasingly likely that
there is an association between Chantix and serious neuropsychiatric
symptoms.

As a result, FDA requested that Pfizer, the manufacturer of Chantix, elevate
the prominence of this safety information to the WARNINGS and PRECAUTIONS
sections of the Chantix prescribing information. In addition, FDA is working
with Pfizer to finalize a Medication Guide for patients.



--
Best Regards,
~Echo

> These symptoms include changes in behavior, agitation, depressed mood,
> suicidal ideation, and attempted and completed suicide.

Not to belittle the warnings but Chantix absolutely changed my
behavior.
And, it helped me stop a very slow, ugly suicide.

One of my dr's warned me about the depression problem as I'm already on
anti-depressants. I appreciated the warning and yes, if there is that
serious of a problem, the consumer should most certainly be aware of it.

I just see a lot of people not even trying it now. I went into it fully
aware of the cautions. So far, this has not only not made me depressed, but
I went thru the first 2 weeks of not smoking without irratability (and i'm a
crabass on a good day).

Another thing they said that I don't totally agree with - is that if a
person really wants to quit, the Chantix would help.

I was no where near ready to quit. I came to this forum and everyone said
just start taking it and I did. I could see how easy it would be to quit
and just went for it.

You hear an awful lot of people say "if I can quit, anyone can". That would
be me! 2 to 3 pack a day habit for 35+ yrs. and I quit almost painlessly.

I think people need to hear the good also.

Kathy
---
1w 6d 14:45 smoke-free, 673 cigs not smoked, $43.75 saved, 2d 8:05 life
saved

On Feb 2, 11:57*am, "Kathy Doherty" <kd60...@sbcglobal.net> wrote:
> One of my dr's warned me about the depression problem as I'm already on
> anti-depressants. *I appreciated the warning and yes, if there is that
> serious of a problem, the consumer should most certainly be aware of it.
>
> I just see a lot of people not even trying it now. *I went into it fully
> aware of the cautions. *So far, this has not only not made me depressed,but
> I went thru the first 2 weeks of not smoking without irratability (and i'ma
> crabass on a good day).
>
> Another thing they said that I don't totally agree with - is that if a
> person really wants to quit, the Chantix would help.
>
> I was no where near ready to quit. *I came to this forum and everyone said
> just start taking it and I did. *I could see how easy it would be to quit
> and just went for it.
>
> You hear an awful lot of people say "if I can quit, anyone can". *That would
> be me! *2 to 3 pack a day habit for 35+ yrs. and I quit almost painlessly.
>
> I think people need to hear the good also.
>
> Kathy
> ---
> 1w 6d 14:45 smoke-free, 673 cigs not smoked, $43.75 saved, 2d 8:05 life
> saved

Yay you!!! I mean, abosolutely, yay you!!
You jump right in there and tell the truth!!!!!!