Thursday, July 2, 2009

FDA monitoring of chantix leads to stronger suicide warning.

"FDA: Stop-smoking drugs Chantix, Zyban must carry suicide warning"
-USA Today.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm

Meds vs. therapy. Therapy wins this one. for the past several years, Pfizer has been marketing Chantix to help people stop smoking. It works for some. Yet, for some, it causes aggressive impulsiveness that can lead to homicide or suicide.

At the same time, we all know that millions of people have quit smoking without taking Chantix. There are more former-smokers out there than there are smokers. We all can simply ask amongst friends and family and discover people who were regular smokers, and who figured out a way to quit, without Chantix, and have stayed smoke-free for a week, a month, a year, 2 years, 10 years, 20 years, 30 years.

Some did it on their own. Some did it with some kind of help - maybe counseling based on motivational interviewing, maybe not. Maybe with the aid of hypnosis, maybe not. Maybe because laws changed, or prices increased, and the balance between pleasure and hassle shifted enough for them to finally quit. Maybe because illness appeared, and a doc told them to quit. Maybe they substituted candy, or nicotine-replacement gum, or the patch, or herbs, or vitamin E. There have been a great deal of resaerch studies showing that therapeutic interventions can increase the portion of smokers who succeed quitting, compared to solo attempts. But it is surely the minority of former smokers who quit with psychiatric drugs, such as Chantix.

But if Chantix helps, why not?

FDA is stepping up its suicidality warning level on Chantix, the stop-smoking drug - that happens to affect serotonin, as do the SSRIs and the SNRIs. Suicide in non-depressed people associated with this brain drug: time to start paying attention.

To understand what is really going on with a drug, you need a great amount of data. You can't make a decision based on the bad, or good, experience of one person, or of a few people. Scientifically, it takes trained epidemiologists to guide the rest of us as we try to interpret the informaiton coming out of various sources of data.

This is one of the challenges that has been involved when trying to detect the problem of suicidality caused by antidepressants - the tough part is that at the same time you have a population where suicidality will be present anyway. That population could be prescribed lollipops and you would notice some suicidality - thoughts, attempts, and actual suicides. This aspect is used by the psychiatrists and pharmaceutical companies to hide the signal that is coming through the noise.

Many physicians attribute suicidality to the depression, not to the drug. So, when suicidality happens, the physician does not go through the effort to send an "adverse event" report to the FDA.

However, with a stop-smoking drug, this confusion is not there. You have a smoking population, not a population of people who have suicidality as a symptom. Tragically, it may be the use of these antidepressants in non-depressed populations that makes the problem blatently clear enough for people to begin to act responsibly.

Cafepharma is a website where people involved with the pharmaceutical industry share and discuss issues realted to their business. They have a discussion board. when FDA started posting warnings about Chantix for smoking, bck in 2007, this was discussed by some of the people visiting the Cafepharma discussion boards. Along with a million other views, here are a couple posts that show the chantix-suicide problem. Keep in mind: these are generally pharma-positive people, and these are spontaneously posted remarks - they were not solicitied for a lawyer, for a documentary, to get disability benefits, etc.

"I wanted to post a Blog about my most recent experience with Chantix. My reason is that my doctor did not make me aware of the Suicide scare. I left my doc's office with a script for Chantix and no direction. Chantix worked very well for me. I quit smoking my third day on the medication. After 21 years. I was never able to double my dosage by day 7 to 1 mg. in morning and 1 at night due to extreme nausea and dizziness. I stayed at .5 morning .5 night. Had major dreams..which I liked..I could feel textures, smell, taste, feel heat and OMG what an imagination I must have. I had few problems associated with the whole stop smoking experience. Limited events of feeling over whelmed or Nicotine fits. Very few temtation moments after the first week. Everything went smooth some slight nausea till my 48th day on Chantix. Probably the best week of my life and I went to bed with an overwhelming feeling of wanting to kill myself. Like a driving voice telling me to. Like my thoughts were..OH GOD I CANT PAY THIS BILL..JUST SLICE MY WRISIT AND NO MORE WORRIES..I was hardcore..and lasted days..Some major meltdowns also durning that few days. The only thing that I think really saved me is my friend telling me of the news about suicides and murders associated with Chantix users..I thought that oh here someone goes raining on my parade. But I am glad because what little sanity I had left made me relize that it was the medicine talking. I stopped the night of my first vivid suicide thought. 48 days into half dosing of Chantix. It was a very scary experience, ruined my Holiday but I didnt jump off the bridge. I just wanted to post my feeling and experience hoping that someone might see the signs and relize it before it is to late.
I am still smoke free 61 days now. I owe it to Chantix it made it an almost painless experience..But I did feel some major effects in the end. Good luck to all on it.
Angel in Seattle"

Anonymous:"This is not a joke and I resent those on this board making suicide jokes or claiming that there is no validity to the Chantix-suicide link.
My father was happy, fulfilled, had a 1 year old granddaughter, great job making great money, no debt, beautiful house, and was retiring in a few years. He had no previous depression or psychological issues of any kind and no indication of suicide. Yet, 6 months ago, after taking Chantix for 2 months, he went into a field near his home and shot himself with a rifle. I lost my hero, my daughter lost her grandpa, my grandfather lost his son, my aunt lost her brother, and my husband lost his best friend.
How funny is it now? This is happening, and families are losing loved ones. Our family will never be the same. Maybe you should think before you write."

Those stories are chilling. If there is something going on, I want to know.

Darkly, some commentors joke that if a peson commits suicide, then they get counted in the portion of people no longer smoking. True. sick, but true.

--Sure, maybe the suicidality in these two anecdotes had nothing to do with Chantix. How to decide? Decent epidemiology. The FDA keeps getting these reports. but mainly, we need to have a general belief, amongst prescribers, that drugs, especially these serotonin-affecting drugs, affecting the brain can, in some cases, cause aggressive thoughts and impulsiveness. Then docs would report cases more frequently. And then could advise patients properly.

Each person receiving a prescription could be informed by the doc: "OK, this drug might help you quit smoking. However, for a small portion of people, maybe 3-5%, they experience thoughts of suicide or homicide, which have for some resulted in murder or suicide. so, if that occurs for you, stop the medication. If you feel like the urges for you get strong, call 911 or call my beeper."

Maybe, each person Rx chantix could be required to have a family member be informed so they could monitor this.

Maybe, at this point, a lot of people would redouble their efforts to quit without a psychaitric medication.

Most smokers have had a successful quit experience. All they need to do is repeat what worked before. They successfully quit with their own therapy, or were guided by some kind of therapy. Rarely have meds been responsible. The smoker has gotten back into smoking, and just needs to get back to what worked before. Easier said than done, but the fact remains that people quit without meds. Meds vs. therapy. Therapy wins this one.

1 comment:

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