Wednesday, November 21, 2007

Chantix / FDA - Do Be Careful Part 2

Today is Smoke-free Day 157 (well, it will be when I wake up since I'm in no danger of smoking in my sleep now that I'm headed to bed).

I've already said "Do Be Careful Out There On Chantix," and I meant it. I'm a success story so far. Lots of the other Chantix bloggers to the side are, too. That's wonderful. Chantix has worked just as it was supposed to for lots of us with no serious side effects. Two words: I'm grateful.

That said, I feel like a broken record sometimes saying that it is important to talk to your doctor if something seems off and beyond the scope of typical nicotine withdrawal symptoms. Frankly, it plain scares the pants off of me when people talk about some really oddball or bothersome possible side effect going on, but then they won't talk to their doctors to make sure all is OK. We as patients on any medication simply *must* pay attention and report any real oddities.

I still feel very much the same as I did when I wrote my "Do Be Careful Out There On Chantix," post (where I had the energy to get into it in more detail than right at this moment) - nutshell version: new drugs are risky, smoking seemed in own opinion just for myself to be more certainly risky and poisonous than new drugs, so I was content to take a risk with Chantix, and it worked, so I'm glad, but I am not you, so you have to do your own research, soul searching, butt searching, whatever other searching and determine whether this Chantix method is a good thing for you to consider along with your own doctor.

I have no idea what the FDA will actually determine, but I'll definitely be interested to hear, and this is in the news and worth at least being aware of as part of being an informed patient. Chris noticed this, too, so thanks, Chris for the heads up (and for the FreeRice site info - loved it so much I added a banner to my page so I remember to click often). There are tons of articles in the news, but here is the FDA's release:
FDA Issues Early Communication for Chantix

Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.

FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.

Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.

FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.

In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.

FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.

Full text of the Early Communication about the Ongoing Safety Review can be found at: http://www.fda.gov/cder/drug/early_comm/varenicline.htm.

3 comments:

  1. Maggie - Because I am new to your comments, I want to say first of all that you are a true inspiration! I found your blog after I started Chantix just about a month ago ... I am now 17 days smoke free. I stopped taking Chantix because of the drowsiness. I actually regretted stopping because I kind of liked the "mellow" feeling that came along with it. I felt very much the way you did in the beginning, that the risk I was taking by continuing to smoke was much greater than the risk of side effects.

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  2. Tomorrow let's all be thankful for the benefit of the drug, the support and inspiration of others, and our determination. Happy Thanksgiving!

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  3. Barbara, thank you for your kind words, and good for you sticking with quitting smoking. I am sorry to hear that you had to stop the Chantix, but it sounds like you are well on your way, and that's wonderful!

    Amen, Chris, to all of the above.

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