Chantix Faces Further FDA Scrutiny

Chantix Faces Further FDA Scrutiny
October 28, 2008

News Summary

The Food and Drug Administration (FDA) may issue a revision of its warning on Pfizer's controversial smoking-cessation drug Chantix, the Wall Street Journal reported Oct. 23.

Just a few months after Pfizer relaunched television advertisements for the drug, the Institute for Safe Medication Practices released a report highlighting 1,001 recent, serious incidents involving Chantix. Of these, 15 were related to traffic accidents and 52 were connected to blackouts.

"The most alarming thing about the numbers is the increase in loss of consciousness like a blackout, and the sudden [temporary] loss of vision," said report co-author Curt Furberg, a professor at Wake Forest University's medical school. "That's potentially very dangerous for everyone, as the traffic-accident numbers show."

"The FDA is reviewing these reports to see if current labeling related to accidents after varenicline [Chantix] is adequate," the government agency said in a statement. The FDA issued a warning last spring after the Institute published a report linking 173 accidents to the drug, and numerous cases of psychiatric side effects were documented.

Pfizer defends the product, saying that these reports "are often unverifiable and lack sufficient medical information to draw any conclusions." Pfizer maintains that Chantix is "an important treatment option to help patients stop smoking."

COMMENTS ON THIS ARTICLE:

Posted by James R on 29 Oct 08 12:23 PM EDT

Pfizer does seems confused to how they should handle this time-bomb. Probably because Chantix is a whole different animal. It seems that this drug deeply affects many patients, making basic thinking processes diffucult or sometimes impossible. In some people, it seems to alter reality, making it very hard them to determine how bad off they really are, both mentally and physically. More testing and trials are definitely appropiate with this drug. Apparently, Pfizer has chosen to blame patients who have reported their experiences to the FDA via the MedWatch reporting system. Pfizer also claims that nicotine withdrawal is a reasonable explanation as to why patients have had phychotic episodes. I find that hard to believe. Maybe Pfizer should concentrate on how this medicine causes changes in the brain's normal functions, including how long it may take for patients to start feeling normal again, if ever.

Posted by joda on 31 Oct 08 03:43 PM EDT

Before we throw the baby out with the bathwater, we need to proceed with caution about banning a medication that has helped literally thousands of people like myself kick the tobacco habit. I smoked for over thirty years and Chantix helped me turn into a non-smoker in 90 days. Almost immediately, within days my smoking was cut in half! I can best describe it as: it left me "off at my last cigarette" with the consistent feeling of "I just had one". It removed my appetite for tobacco. It is truly a remarkable medication and like any form of treatment, whether M.A.T.,behavior modification, self-help, hypnosis, or group therapy, it is not "one size fits all". It is what WORKS FOR THE INDIVIDUAL that counts. Any negative side-effects related to Chantix need to be addressed on a case by case basis with a physcian. To be qiute honest, I sort of dug the vivid dreaming.

Posted by non-smoker on 04 Nov 08 09:16 AM EST

I agree with Joda. My husband and I both smoked for most of our lives and had tried quitting many times but never succeeded for more than a few days to (once) three months. We used Chantix and have been smoke free for 1 1/2 yrs. With hindsight, we probably were quicker to anger when on Chantix - but that was 3 months of our lives. Without Chantix, our quality and quantity of life would have been greatly dimished. My spouse already has COPD; it would be much worse if he had continued to smoke this past 1 1/2 yrs. Instead, for the first time, there has been no worsening of his condition. People may need to be aware of potential problems, but it is just as irresponsible to toss a drug that may literally save lives as it is to be too lax in the controls.

Posted by Dawn A on 04 Nov 08 11:38 AM EST

I too have had significant benefit from using Chantix. I read about the medication and talked to others before taking it so I knew what to expect and what to look for. I have told many that the positive effect well out weighed the side effects I experienced(nausesa for about 1 hr after taking and the vivid dreaming). Like all medications, OTC, and herbals, everything has a potential side effect. An informed consumer is the best consumer. I usually do not like to take prescription meds but being a nicotine addict was causing more problems.I agree with Pfizer that the reports of serious side effects need to be relaibly verified because the potential long term benefits of this medication are extremeely significant. I believe doctors should monitor this more closely and patients have a responsibility to monitor their own symptoms as well.

Posted by Agnes on 24 Nov 08 02:12 PM EST

I have been smoke free for one year, almost to the day, thanks to Chantix. I experienced nausea and vivid dreams, but my desire to quit without going insane was strong, and my lungs weak, so I kept on going. My experience has shown me that there is always a reason to fail - succeeding is much harder. Quit making excuses!

Posted by John Bancroft on 16 Apr 09 10:26 AM EDT

Look at the facts. The Surgeon General’s warning has done little to stop smoking. Big Pharma doesnt really want people to quit smoking because they lose their cash cow and "annuity" if they lose the customers in their smoking cessation universe. Anti-smoking regulations are a joke an not enforceable. NIH, NCI and NIDA all propose a harm reduction approach to smoking and tobacco use. But what the hell is that? AND … Pfizer knows that there are natural botanicals with neurobiological activity similar to Chantix on A4B2 receptors sub sets and these natural botanicals like lobeline have none of the adversities of Chantix. My advice: Don't try to quit smoking until you are ready to quit smoking. Stop letting friends and family brow beat you into failure in your attempts to stop smoking. Find an approach that works for you. Look for natural alternatives products that can help you get past the cravings.

Patch Makers Say FDA Rules Prevent Use

Acomplia Shows Promise as Anti-Craving Drug

FDA Allows Test of 'Liquid Cigarette'

Problems Could Affect Chantix Bottom Line

Smokefree.gov

A Decade of Broken Promises: The 1998 State Tobacco Settlement Ten Years Later