Tuesday, February 05, 2008

Chantix / FDA - Do Be Careful Part 3

Today is smoke-free day 232, and I'm a happy girl (well, other than the whole it being Monday again thing).

I have a feeling there will be more of these installments (if you missed the exciting Part 1 and Part 2 click on the links), but here we go with Part 3.

I'm one of those who took Chantix with few real side effects (some nausea, some gas that I didn't detail much because farting for an audience isn't really attractive even for me, and some crazy dreams that were the fun and enjoyable kind that I kind of miss). Considering that I quit back on June 18, 2007 and am still not smoking (minus that little oops in October that I nipped in the bud and kept going), I'd say that Chantix did for me what it was supposed to, as it was supposed to and with results even better than I'd expected. I remain grateful that my dear friend J told me about his success because I had no idea that there was such thing or that both dedicated smokers that we were us would both be sitting here now each this far into being quit (he's a month or two ahead of me). Lots of other bloggers (great, supportive and wonderful people) have shared their experiences with Chantix, and it's been a mixed bag but still with lots of success stories and people happily through the worst of quitting smoking and many long past the last Chantix dose doing just fine (my last dose was September 6, 2007, but it was a small dose since I chose to taper off Chantix once my doctor OK'd).

All that said, I am not every person in the world (thankfully), and people really, truly, really, seriously, I mean it, really need to educate themselves about any drug they are putting into their bodies, especially newer drugs. It is also, in my opinion, imperative that people be under the care of a real medical doctor when taking prescriptions like this (and not one of those crazy and irresponsible mail order prescription deals where it's just an interview from a doctor with no follow up or recourse if things get nutty or something). Some people probably shouldn't take Chantix. Other people probably shouldn't continue smoking when there might be that kind of help available. While I usually think I know everything (and I'm usually right), I can't say who is who other than to say that I was in the latter category. I read, I researched, I took my chances with the devil I didn't know because I was pretty well convinced that the smoking devil I did know was not good for me and was actually poisonous. I get it that plenty of folks prefer the devil they know to the one they don't. Your body, your call. I'm happy with my decision. No, thrilled, delighted, even.

For the love of Peanut Butter and Pickles, please do be careful out there on Chantix. Read, research, talk to your doctor, understand the risks and THEN make your decision. If Chantix isn't going to be the right thing for you, know that bazillions of people have quit smoking a mazillion other ways when they wanted to quit (though I found this route easier for me personally).

And without further Maggie-ramble, on with the bit of news from the Associated Press article (scroll down for actual FDA warning).
FDA: Chantix May Pose Psychiatric Risks

By MATTHEW PERRONE – 2 days ago

WASHINGTON (AP) — Government regulators said Friday the connection between Pfizer's anti-smoking drug Chantix and serious psychiatric problems is "increasingly likely."

The Food and Drug Administration said it has received reports of 37 suicides and more than 400 of suicidal behavior in connection with the drug. In November, the agency began investigating reports of depression, agitation and suicidal behavior among patients taking the popular twice-daily pill.

The agency's announcement comes two weeks after Pfizer added stronger warnings to the drug. In doing so, the company stressed that a direct link between Chantix and the reported psychiatric problems has not been established, but could not be ruled out.

Pfizer suggested that since nicotine withdrawal alone can cause mood swings and agitation, it may be impossible to determine if Chantix aggravates those behaviors.

But FDA said it found evidence of Chantix patients who experienced psychiatric problems even though they were still smoking.

"There are a number of compelling cases that look like they are the result of exposure to the drug itself and not other causes," said Bob Rappaport, a director at FDA's drug evaluation center. Some patients experienced the same psychiatric problems after they stopped using Chantix, he said, suggesting a negative reaction to withdrawal.

In a public advisory released Friday, FDA said patients taking Chantix should tell their doctor about any history of mental illness. Patients and family members should watch for any changes in mood and behavior.

"Chantix may cause worsening of current psychiatric illness even if it is currently under control," reads the statement. "It may also cause an old psychiatric illness to reoccur."

FDA noted that patients with psychiatric problems were not included in the original studies used to test Chantix's safety.

Approved in May 2006, Chantix, already prescribed 4 million times in the U.S., has been one of the few bright spots on Pfizer's balance sheet. For full-year 2007, the drug had sales of $883 million, helping offset lower sales of older drugs, such as the antidepressant Zoloft, which face generic competition.

The tablets work by binding to nicotine receptors in the brain, reducing the symptoms of withdrawal.

GlaxoSmithKline makes Zyban, the only other non-nicotine, anti-smoking drug for sale in the U.S. Part of the antidepressant drug class, Zyban includes warnings about increased suicidal behavior.

Shares of Pfizer Inc. rose 23 cents to close at $23.59 Friday.
And from the horse's mouth, the FDA:
FDA Issues Public Health Advisory on Chantix
Agency requests that manufacturer add new safety warnings for smoking cessation drug

The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

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. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals and patients informed of new and emerging safety data.

"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said Bob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products. "While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug."

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug's approval.

Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor.

Vivid, unusual, or strange dreams may occur while taking Chantix.

Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA's continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency's continuing reviews and conclusions warrant.

For more information:
http://www.fda.gov/cder/drug/infopage/varenicline/default.htm
So, there you have it. You've been warned. Me? I'm off to go sing at the top of my lungs, get aerobic just because lung function now allows, laugh my left arm off until I pee myself and cry rivers of joy but still not have to cough to the point of almost puking like I did in the bad old days and then go live another X number of years because I'm one of the success stories. And I am grateful. And I would still recommend that anyone wanting to quit smoking consider Chantix as one possible option to discuss with a real live and preferably trusted doctor while also considering the possible risks involved. Disclaimer much?

9 comments:

  1. I quit smoking a few years ago. But about once every two months I will smoke a whole pack of cigarettes in one night. (I know. I know). It's usually if I'm having drinks with friends or something. But still, I need to stop even doing that.

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  2. I'm really happy for you. My pop died of cancer caused from smoking. He also lived 10 yrs w/o a voice box b/c of smoking. That was my incentive to quit. It was really hard, but worth it. Good for you!

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  3. Thanks, Tasina, deep ;)

    Amanda, to this day, if I thought I could smoke sometimes, I probably would, but I just can't ever seem to pull it off without getting sucked back into it full-time.

    Wow, Kelly, that gives me incentive to stay quit. Scary stuff.

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  4. I have an online friend whom I suggested Chantix to. She said, "Isn't that the drug where you go crazy?" I dropped it, because I didn't know enough about it. I only knew that my other online friend [you] had major success with it.

    Usually, I'm against any chemicals/medicine. But, in this case, with the guidance of a medical professional, I would probably be open to it if I were a smoker.

    Good for writing this, Maggie. You are a good woman!! <3

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  5. I agree, Mishelle. Even knowing the risks, I'd probably have still given it a try with both eyes wide, wide open.

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  6. I saw an article the other day talking about the same disclaimer. I had heard the warnings before they were admitting to them and still went ahead and took the drug. I told all of my friends and family to watch me closely and made them promise to tell me if they noticed any changes in me.

    Even knowing that they are warning people to watch for these side effects, I'd still take it. I'd go about it the same way - having people to keep a close eye on me.

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  7. I am glad I did the Chantix. I got an extension from my doctor and will probably taper off given the most recent reports. I had the same kind of symptoms as Maggie and if I did feel homicidial or suicidal I would have called my doctor and discontinued the medication. I did become homicidal when I was taking Wellbutrian/Zyban or whatever they call it now. (Thats a whole other story)

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  8. Lynda, I think there is much to be said for having people keep an eye on anything out of the ordinary. People in our lives might notice before we even do and before our doctors would notice.

    Mz Diva, glad you also are not having the same problems as on the other attempts. That would be scary.

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