Not Sure About Taking Champix - FDA Warning

[lallieth]

Champix or Chantix in the US is what I was given to help me quit smoking.While I was told it has a good success rate I found out that on Feb 1.2008 the FDA issued a public health advisory on the medication and this really concerns me.My dr didn't mention this when we talked about taking the meds

FOR IMMEDIATE RELEASE
February 1, 2008
FDA News

FDA Issues Public Health Advisory on Chantix

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.

 

[Into The Light]

Re: Not Sure About Taking Champix-FDA Warning

this is just an opinion and by no means am i saying i am right or wrong, this is just what comes to mind when i see the article you quoted.

i kind of struggle a bit with the FDA just because of the whole thing with them issuing warnings about anti-depressants increasing thoughts of suicide, while in fact there was never really a clear link, and in fact i believe there was a rise in suicide rates because anti-depressants were not being prescribed as much because of their warning. that said, i certainly am not suggesting that you ignore what the FDA issues for warnings. i think they are trying to err on the side of caution by bringing these things to the public's attention.

what i would do is bring a copy of this article to your doctor and discuss your concerns with him/her. if it is a matter of closely monitoring your moods to ensure that nothing out of the ordinary is overlooked, then you may in the end decide to go ahead and take this drug. in the end, i think these things always come down to a cost benefit analysis, and for you personally do the benefits outweigh the risks is what you need to figure out.

 

[Halo]

Re: Not Sure About Taking Champix-FDA Warning

While I understand that it may be scary to begin taking this medication due to the "potential" side effects but like the article states it is about weighing the risks v. benefits. I also think that the most important part of the article was this:

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

To be honest every medication comes with its list of potential side effects however with this one I think the major thing is to be aware of any sudden changes listed that could be a potential side effect.

I think that only you can know whether taking this medication is the right decision for you but I am sure that with your doctors input you will make the right decision.

 

[lallieth]

Halo I agree,but with taking any new medication I get a little nervous.The nurse at the Heart institute assured me (as did my dr) that Champix is NOT like Wellbutrin (zyban)because I had a bad experience on Wellbutrin.

 

[Halo]

Halo I agree,but with taking any new medication I get a little nervous.The nurse at the Heart institute assured me (as did my dr) that Champix is NOT like Wellbutrin (zyban)because I had a bad experience on Wellbutrin.

I think that anyone that begins a new medication may have some hesitations knowing that there are potential side effects but again it is benefits vs. risks. I am glad that you have spoken to both the nurse and the doctor and they are aware of the new medication and together you all can keep an eye out for any adverse side effects.