And the winner is...Chantix

[Vocalek]

http://www.ismp.org/QuarterWatch/2008Q1.pdf

According to a report by the Institute for Safe Medication Practices dated October 2008, a record number of deaths and serious injuries associated with drug therpy were recorded during the 1st quarter of 2008. Chantix accounted for more serious injuries than any other prescription drug, a total of 1001 new cases, including 50 new deaths.

Remember, this is for one quarter -- three months!

I went looking for a more recent report and found the 2008Q3 report (http://www.ismp.org/QuarterWatch/2008Q3.pdf):

In this later report they focused on a possible link between Chantix and violence toward others. The ISMP Quarterwatch program found 30 possible cases reporting physical assault, 148 mentioning homicidal thoughts, and 331 cases of aggressive behavior since the drug was released.

In addition, ISMP expressed concern about the potential to cause motor vehicle and other accidents because of effects on memory, mood, and motor control.

 

[Vocalek]

Just found this report. Strong Signal Seen on New Varenicline Risks

It gives more details concerning the types of problems reported. In addition to accidents (mentioned in first post), it talks about disturbances in heart rhythm, vision disturbances (might contribute to the accidents!), seizures, and loss of glycemic control.

Also discussed are hallucinations, sudden loss of consciouness, paranoia and psychosis.

The actual number of events is reported in Table 4 of the report. I am, to say the least, appalled.

 

[eric]

Jeez! This is horrible!

Great find and even better research, Vocalek, and thanks for bringing this matter to light!

 

[Porphy]

Wait wait wait... isn't that approved by the FDA? Sorry to side track this thread but that would seem like a lapse in good judgment if it was so.

 

[Vocalek]

That's right on point, Porphy. Yes, Chantix is FDA approved. You need to understand that clinical trials the FDA requires for approval are almost never conducted on a cross-section of folks likely to use the drug. Instead, anyone with any type of health problem is disqualified from being included in the testing. Therefore, it is not until after approval that we find out how "safe" the drug really is -- or even how effective it is.

Until recently, women of child-bearing age were routinely prohibited from participating in clinical trails. And some medicines that work for men, don't work for women, and/or dosage needs are very different.

I was always leery of Chantix, after I learned that it works by blocking dopamine receptors. Theory being that dopamine is where the pleasure center is and if we just take away the pleasure of smoking...

Problem is that for many people, the result is dysphoria (the inability to feel pleasure). It is especially difficult on people with a tendency toward depression. Furthermore, dopamine has many more functions than enabling the feeling of pleasure. It is very important in maintaining concentration and working memory.

 

[Fredrick]

Just found this report. Strong Signal Seen on New Varenicline Risks

It gives more details concerning the types of problems reported. In addition to accidents (mentioned in first post), it talks about disturbances in heart rhythm, vision disturbances (might contribute to the accidents!), seizures, and loss of glycemic control.

Also discussed are hallucinations, sudden loss of consciouness, paranoia and psychosis.

I was victim to almost all of the above stated side effects. I was "laid-off", and sent packing. Vision would blur occasionally for short periods of time, paranoia ran my life for about 2 weeks, until one day I finally seizured at work in the morning and woke up in the hospital. The psychosis started 1 week after weening off of the drug, and lasted for 8 weeks. A month after coming off of it I was the under the care of a psycologist, who actually tried to put me back on Chantix, after I told him I would still like to quit smoking. I was still out-of-my-mind-crazy, but I still knew well enough to say no. That stuff is the F'in Devil!

EDIT: Gotta love a "Black Box" warning almost a year after you're declared crazy becasue of a prescription you were given.

 

[kardjunkie]

Sorry about your experience Fredrick, sounds horrible. Don't touch those e-cigs though we really don't know how safe they are. Maybe you should just you should just try another FDA approved device.

BTW I am not making fun of your experience, it sounds like it was something i would not wish on anyone, just at the FDA!

 

[ProtoType]

Amazing. Thanks for publishing this. It is funny I have the prescription for Chantix, the card coupon, and the pamphlet in my car. It's been there since April/May. June is when I started vaping because of my gf.

I never gave Chantix a try and am glad as hell I didn't now.

 

[AVITWeb]

Amazing. Thanks for publishing this. It is funny I have the prescription for Chantix, the card coupon, and the pamphlet in my car. It's been there since April/May. June is when I started vaping because of my gf.

I never gave Chantix a try and am glad as hell I didn't now.

Yet another reason they want to ban e-cigs.....Big Pharma....The money between them and Big tobacco could fund an entirely new 1st world coutry complete with monorails and character photos....the NEW Disneyworld!

 

[PakAdayX50]

Yet another reason they want to ban e-cigs.....Big Pharma....The money between them and Big tobacco could fund an entirely new 1st world coutry complete with monorails and character photos....the NEW Disneyworld!

I think Big Pharma is THE reason for the FDA activity against e-cigs. Tobacco has had a long term relationship with Congress, but the FDA has been in bed with the pharmaceutical industry for decades.

 

[Vocalek]

Received today from FDA Medwatch:

BOXED WARNING

• Serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide have been reported in patients taking Chantix...

WARNINGS

Neuropsychiatric Symptoms and Suicidality

• Serious neuropsychiatric symptoms have been reported in patients being treated with Chantix. These post-marketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide...
• Advise patients and caregivers that the patient should stop taking CHANTIX and contact a health care provider immediately if agitation, depressed mood, changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of CHANTIX was reported although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.