Furious Seasons

May 22, 2008

Chantix's Ugly Side Effects And Pfizer's Responsible Behavior

I've had a look at the report by the Institute for Safe Medication Practices that spurred yesterday's FAA ban on the use of Chantix, the stop smoking drug, by pilots and air traffic controllers and that report is a doozy. From Bloomberg:

"Among the psychological side effects reported to the FDA were 28 suicides, 41 cases of homicidal thinking, 224 reports of heart trouble, 525 reports of hostility or aggression, and 397 cases of possible psychosis. There were also 173 serious injuries, including traffic accidents often associated with unconsciousness, dizziness, muscle spasms, or mental confusion."

Last year, when I wrote that this drug was acting like a bad old SSRI, I was attacked for making the association. Now, it's apparent that the report, based on the FDA's adverse events database, backs my concerns about the drug. In its two years of market life, the drug has generated more than 3,000 reports to the FDA (of course, the public and docs are a bit more attuned to the fact that they can report problems with drugs to the FDA these days than they were a few years ago). In a 10-year period, Paxil generated about 8,000 adverse events reports. By comparison, Chantix is like the Son of Frankenstein. Of course, it's never 100 percent clear if a drug is responsible for problem X, but based upon the many accounts of Chantix users who've written to this site, I'd say the drug has the unique ability to make regular folks crazy. And, it says quite a bit that the FAA banned the drug's use. That's not an agency that's prone to overreaction.

The rolling set of warnings the FDA has placed on the drug and Pfizer's own warning label (in advance of what would've been an almost certain black box warning by the FDA) have knocked sales of the drug down by one-third and financial analysts have downgraded future sales for the drug as well.

"The new report prompted Sanford C. Bernstein & Co. analyst Tim Anderson to cut his sales estimates for the drug by 42 percent, to $758 million from $1.31 billion, in 2009 and by 60 percent, to $720 million from $1.82 billion, in 2015."

That's a whole bunch of change going down the sewer. I often bang on the behavior of pharmaceutical companies in relation to hiding problems or non-performance issues with their drugs, but in this case Pfizer gets high marks from me for its behavior and its willingness to be proactive while inevitably knowing that it was hurting itself on the revenue front. The first very public reports of problems with the drug came in from late-September through early November of last year. Only a few months later, the FDA had issued warnings and Pfizer had voluntarily stepped up to the plate and issued its own version of a black box warning (after spending a few months trying to blame some of the effects of the drug on the effects of quitting smoking). Compared with how Eli Lilly covered up known problems from the late-90s onward with Zyprexa and then spent two years negotiating terms of the FDA black box warning, insisting all along that the drug was no problem, this is about as ethical as it gets in the pharma world.

Then again, company officials likely knew that if they didn't respond, the FDA would force a black box down its throat, and the company would be sued into infinity by plaintiff's attorneys. It still might be for all I know.

It's a pity Lilly wasn't as upfront with Prozac and Zyprexa. Lives would've been spared. But then you could say the same about the companies that make Paxil and Zoloft and Effexor and, well, you get the picture.

Posted by Philip Dawdy at May 22, 2008 09:16 AM

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Comments

Bloomberg is a good resource of information about medicine.
From the news:
"China Seeks Psychiatric Help Worldwide for `Huge' Quake Trauma" we not only know that psychiatrists are doing the job of psychologists and also how will China will receive all the benefits the western have:

Globalization and its Impact on Mental Health in China

"Overall, China remains a developing country with insufficient mental health resources, characterized by a very low treatment rate in mental illed: less than 50% for schizophrenia and other psychotic disorders, as well as less than 10% for common mental disorders, for example, affective disorders, anxiety disorders and substance abuse. China’s mental health planning for 2002-2010 listed the enhancement of treatment rate as its specific objective, which is regarded as relatively practical and realistic.
Globalization is also an opportunity for mental health in China. China may and should learn from the experience and lessons of other countries in developing mental health and formulate its own strategy with the integration of local situation. This would avoid detours. From this perspective, China should extend its gratitude to global mental health teachers."

http://www.21jk.com/p/csp/papercontent.asp?recordid=4396

I've open a blog but still don't know what to do.
Not even in what language I'll write. LOL
In this terrible English I write when approaching this subject because I get too emotional or in Portuguese that has the chance to be hacked after 1 month. LOL
druggalized. . .. is the name. I'll not give the full address because it's still under construction.
Wait and see!
LOL LOL

Another interesting news on Bloomberg:

Posted by: Ana at May 23, 2008 01:19 PM

I took Chantix to stop smoking last December. I took them for 30 days. They drove me straight up a wall. They are horrible. I started smoking again, they drove me so nuts!

Posted by: ginger at May 26, 2008 01:23 PM

I took Chantixs for five days in feb. 08 ,my klonipin quit working,and Ive been a mental mess ever since.I went from the happiest guy I ever been to not caring If I live or die/people just can't understand what has happened to me ,Im down to no friends and the shrinks can't figure out to do with me,pretty soon there wont be any more me ,I dont drink or do drugs I was already on dissability when this happened for fms and anxiety disorders.. Can some one help me,,,Lowell

Posted by: Lowell at December 30, 2008 11:37 AM

Lowell,

Though I haven't taken Chantix, I have suffered side effects from medications.

You say, "Pretty sooon there won't be any more of me."

Don't give up, you are not alone.

Posted by: Stephany at December 30, 2008 08:39 PM

I filled two Chantix scripts between Oct. 06 to Oct. 07. In Jan. '08, was taken by ambulance with heart attack symptoms along w/fever, radiating stomach pains and horrific headache. Stayed a week, IV's 24/7 w/morphine, antibiotic and oxygen. Underwent several tests. Released w/diagnosis of possible "virus."

May '08, took drive to rural area, found a used car parking lot, parked on an angle to blend in w/other cars, ingested over 240 sleeping pills, and cut self up w/mini diabetic razors, purchased on way to destination. Woke up six days later in ICU, surrounded by family, learned last rites had been given. Woke up when taken off respirator.

Spent time in psyche unit. Was ostracized by almost everyone....they could not believe I could do such a thing...lost babysitting rights to my six beautiful grandchildren and took leave from my job which I love and have had for 22 yrs.

Everything to live for, yet this pill made me feel like it was A-OK to take myself out, in fact, I was more than willing to admit my time here was done. I wasn't mad, sad, glad, nothing, that nite. Flat. That's it. Tired...very, very tired.

Four cigarettes per day is what I was smoking. No one knew I was on Chantix except my mom...and for months she kept feeding me negative side effect articles on Chantix...and I FINALLY sat up and listened. I pray nightly for my day of vindication. I have a GREAT life...I don't want to go anywhere!! Chantix put me in a different state of mind, felt like I was on the outside looking in...as life just passed me by. Wanted desperately to take soft blankey, pillow and go into closet and shut the world out. I mean it...I was wacko!!!

Posted by: Terri at November 23, 2009 12:10 PM