The following is a message from Kim Witczak, a drug safety advocate who is testifying in front of the FDA soon on behalf of users of Chantix who have experienced severe side effects - the FDA are considering removing the black box warning that comes with Chantix.
For those that don't know Chantix is a smoking cessation drug and has a dark history with regard to suicidal and homicidal acts. It's maker, Pfizer, have made many settlements out of court. Chantix is also known as Champix, it's generic name being varenicline.
In 2008 the Federal Aviation Administration [FAA] took the unusual step of banning the use of Chantix after it learned the anti-smoking medicine might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately.
The FAA took this action one week after a medical safety group, the Institute for Safe Medication Practices, released the results of a study that found evidence for the occurrence of seizures, loss of consciousness, heart attacks, vision problems, and various psychiatric instabilities in individuals who use Chantix.
Chantix was the subject of a freedom of information request I made back in April 2010. I had learned that the Federal Aviation Administration [FAA] had changed their policy regarding pilots being allowed to operate aircraft whilst under the influence of SSRi-type medication. The full 58 page document sent to me can be read here.
Here's a message from Kim.
You can contact her with your story via the email address at the end of her message.
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Have you or anyone you know taken Chantix to quit smoking?
The psychiatric side effects of Chantix are moving back to center stage. Later this month the FDA will be holding hearings to decide whether or not to remove or reduce the black box warnings on Chantix.
Chantix came under fire after reports of hostility, suicide, suicide attempts and other psychiatric disturbances such as aggression and nightmares. In 2009 FDA required a "black box" warning (most serious of warnings) on the drug, to alert patients and doctors to the risk of psychiatric side effects.
Now, they are saying after further review the data from recent studies found little or no evidence of psychiatric problems. What gives?
Last year Pfizer settled the majority of its 2,700 lawsuits against it for $275M. Chantix had global sales of $648 million last year. That was down about 26 percent from the drug's peak sales of $883 million in 2007.
How you can help???
In preparation for my testimony at the FDA hearing, I will be representing the voice of people who have experienced psychiatric side effects from taking this drug. If you have a personal story and are willing to share it, please let me know. We need real life experiences vs just what Pfizer shares.
As you many of you know, I have been working on drug safety issues since my husband took his own life after being given antidepressant Zoloft for insomnia in 2003. (At the time there were no warnings on these drugs.) There are many parallels between the narratives surrounding antidepressants and Chantix. There are many, including myself, who believe that this is the first step in undoing the black box warnings for antidepressants.
Warnings are there for a reason. It gives information about a drug's potential risks and what to look for if you or loved one are taking it. You never know if you or your loved one may be the small % of risk. But that small % could be your 100%.
If you have a Chantix story, please share.
Email - Info@woodymatters.com
Bob Fiddaman.
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