*** Good News: 2 Anti-Smoking Drugs Cause SEVERE Mental Health Problems ***
� Reality Check� �
a..
b.. FDA: Chantix and Zyban will carry warnings about mental health risks
c.. Risks include depression and suicidal thoughts when using the drugs
d.. Drug makers must conduct study how often these serious symptoms occur
e.. Some symptoms could be the result of nicotine withdrawal
By Saundra Young
CNN
WASHINGTON (CNN) -- Two popular anti-smoking drugs will now carry warnings
about the risk of severe mental health problems, the Food and Drug
Administration announced Wednesday.
The FDA said Chantix and Zyban will carry the warnings to alert consumers to
the risks of depression and suicidal thoughts when using the drugs.
The drugs also have been reported to cause changes in behavior, hostility
and agitation in users, whether users had a history of psychiatric illness
or not. In many cases, side effects started shortly after use began and
ended when the medication was stopped. The FDA does not know what is causing
the changes and said people taking these products should be monitored by
their doctor.
"The risk of serious adverse events while taking these products must be
weighed against the significant health benefits of quitting smoking," said
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and
Research. "Smoking is the leading cause of preventable disease, disability
and death in the United States, and we know these products are effective
aids in helping people quit."
The agency also is requiring Pfizer Inc., which makes Chantix, and
GlaxoSmithKline, maker of Zyban, to conduct a study looking at how often
these serious symptoms occur.
Pfizer says it updated its label in 2007 to include information of
neuropsychiatric symptoms and has revised the label again to reflect
Wednesday's warning.
"The labeling update underscores the important role of health care providers
in treating smokers attempting to quit and provides specific information
about Chantix and instructions that physicians and patients should follow
closely," said Dr. Briggs W. Morrison, senior vice president of the primary
care development group at Pfizer. "Quitting smoking is one of the best
things people can do for their health, but the quitting process is both
difficult and complex."
The FDA says that since Chantix was approved in 2006, the agency has had
reports of 98 suicides and 188 attempted suicides. Zyban has had reports of
14 suicides and 17 attempts.
Zyban contains the same active ingredient as the antidepressant Wellbutrin
and already carried a box warning about the increased risk of suicidal
thinking and behavior.
Neither Chantix nor Zyban contains nicotine, and the FDA said some symptoms
could be the result of nicotine withdrawal. Still, the agency said, people
using these drugs experienced some of these symptoms while they were still
smoking.
In a review of side effects in patients using the nicotine patch, the agency
said it didn't find a clear link between those products and suicidal events.
===============
Keep Suuuuuuuuuuuucking, Addicts !!
Eldon
Here's the URL you didn't include (though you quoted the whole
article).
http://edition.cnn.com/2009/HEALTH/07/01/fda.anti.smoking.drugs/index.html
And here's another discussion with the Zyban warning reproduced
verbatim.
http://www.cnbc.com/id/31687022
On the FDA conference call with reporters this afternoon to discuss
the new warnings, two agency officials told the news media to use the
phrase "Boxed warning" instead of "Black box warning." Why? As one of
them put it, "Black box carries the implication, 'Don't you dare use
this'." The other official added, "We don't want to scare people off
(from trying to quit smoking). We just want them to be carefully
monitored."
The FDA, Pfizer and GSK are all emphasizing what a health burden
smoking has become. PFE's Director of Worldwide Communications, Sally
Beatty, emailed me to point out that around 70 percent of smokers want
to quit, but only three percent are able to do it on willpower alone.
On average, she added, smokers try six to nine times in their lifetime
to butt out. "We want patients to get the support they need."
When I was growing up my mom was a chain smoker. I hated it. She
finally quit cold turkey years after I moved out of the house. But it
was too late. She developed kidney cancer, which occurs in cigarette
smokers at a much higher rate than non-smokers, and died of metastatic
disease.
Chantix sales have already taken a pretty big hit since the reports of
mental side effects surfaced about a year-and-a-half ago. And Zyban is
a relatively small-selling product for GSK. Sales may shrink even
more, though, now that the drugs are getting a new boxed warning.
There, you happy FDA? I said it. Boxed is the new black.
----
I know the FAA doesn't allow pilots and air traffic controllers to
take Chantix. There was a case in Texas where some guy on it went
berserk and was shot by his neighbor, but it turned out that his blood
alcohol content was .28 percent, which is way up there (the driving
limit being .08).
I wonder if the typical recommended dosages of these drugs are two
high. A few people here have said they stuck with the beginning half
dosages with good results, as did I.
btorvik2
That's the real plan. Kill off all the smokers with drugs.
bernie
--
"Official ASC Shaman"
Bruce Watson
If the tobacco doesn't do it first.
Jim Beard
>>
> And here's another discussion with the Zyban warning reproduced
> verbatim.
> http://www.cnbc.com/id/31687022
>
> On the FDA conference call with reporters this afternoon to discuss
> the new warnings, two agency officials told the news media to use the
> phrase "Boxed warning" instead of "Black box warning." Why? As one of
> them put it, "Black box carries the implication, 'Don't you dare use
> this'." The other official added, "We don't want to scare people off
> (from trying to quit smoking). We just want them to be carefully
> monitored."
Hmmm. The FDA does not want to scare people off from taking
"medications" that may result in users killing themselves or
others due to drug-induced mental health problems. They just
want to be able to say, "You were warned!"
Your Government in action! (Should that be four words, or three?)
No cheers.
jim b.
--
UNIX is not user unfriendly; it merely
expects users to be computer-friendly.