FDA Votes to Keep Warning on Chantix

Despite the protests of the multi-billion dollar pharmaceutical company Pfizer, the FDA have voted to keep the black box warnings on the smoking cessation drug Chantix, known as Champix in Europe.

Only one person of the 11 panel members made up of  the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted to remove the black box warning.

Despite the evidence showing an increase in suicide, aggression and other bizarre side effects  Pfizer's Christopher Wohlberg, MD, PhD, said  "We think the available evidence is inconsistent with a boxed warning."

The panel disagreed and warnings will remain in place.

Below is a video presented to the committee meeting by patient advocate Kim Witczak.

These are actual patient testimonies - something Pfizer should pay heed to.

Bob Fiddaman

Back Stories

Pfizer enters final settlements in 660 Chantix lawsuits

Chantix Class-Action Plaintiff Is Former Pfizer Employee

Passenger Safety - The Champix Scandal

Chantix Dangers

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.

--

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.

Health Canada Bury Heads in Sand over Champix Suicides

Unsurprisingly, the Canadian medicines regulator, Health Canada, are burying their heads in the sand regarding the reported suicides that surround the smoking cessation drug, Champix, also known as Chantix [Varenicline]

Canadian newspaper, The Star, is reporting that their own "investigation has found 24 Canadians taking Champix to quit smoking have killed themselves since it hit the market here in 2007, putting it among the leading suspected causes of reported suicides linked to prescription drugs."

The investigation also found that there was no indication Health Canada has investigated individual cases of psychiatric side effects since it looked into 14 cases of aggression, depression and suicidal thoughts from 2007, adding, Health Canada did a “systematic review” to see if Champix caused psychiatric reactions in 14 cases from 2007, the year the drug came out here.

CHAMPIX IMPLICATED IN MURDER/SUICIDE

Image: medicalspecialists.co.uk

The BBC reported yesterday that an inquest had heard that a man stabbed his wife and smothered his children before killing himself at their Hampshire [UK] home.

The BBC writes:

Andrew Case, 33, was found dead along with wife Vicki, 31, and their two girls Nereya, one, and Phoebe, two, at their home in Fordingbridge in 2010.

He was prescribed an anti-smoking drug, which can have anger side effects, but no traces were found in his blood.

The coroner ruled Mrs Case and her daughters were unlawfully killed and Mr Case killed himself.

The hearing heard Mr Case was originally given 28 Champix anti-smoking tablets on 10 July last year and a further 56 tablets by a chemist on 23 July last year, the day the family had returned from a week-long holiday to Weymouth, Dorset.

The original prescription packet of tablets was found empty in the house and only 28 of the extra tablets were found.

I have highlighted Champix [Varenicline] on this blog many times. Champix, strangely called Chantix in the US, is an anti-cessation smoking drug from the stable of Pfizer. It has been in the news quite frequently but its risks have always been played down by the pharmaceutical giant.

Champix tablets contain the active ingredient varenicline, which is a medicine used to help people who are addicted to nicotine to give up smoking. It acts in the brain, but is not the same as nicotine replacement therapy.

*There have been reports of suicidal thoughts or behaviour in people taking this medicine to help them give up smoking.

Although Chantix [Champix] has never been classed as an antidepressant it does have some indirect actions on dopamine, which is a neurotransmitter that some anti-depressant medications work on.

Back in 2009 I wrote to The Civil Aviation Authority, the UK's specialist aviation regulator, and asked them if Pfizer's Champix had been banned in Pilots. Dr Paul Collins Howgill, Head of Aviation Medicine Training at Gatwick wrote back the following resonse:

Dear Mr Fiddaman

Thank you for your email of the 15th August concerning Varenicline.

I can confirm that the United Kingdom CAA has not permitted pilots or air traffic controllers to take this drug whilst holding a valid UK CAA issued medical certificate. This is because of the side effect profile.

We are also aware that although the FAA initially allowed this drug to be taken by pilots and air traffic controllers certificated by the FAA, they subsequently withdrew this approval.

I am unsure as to what the regualtory policy is in other National Aviation Authorities within Europe.

Kindest regards

Dr Paul Collins Howgil

If Champix/Chantix has been banned for use in pilots and air traffic controllers then one could assume that train drivers and controllers and possibly bus/coach drivers would be told to abstain from this particular drug too?

Some time ago, BBC Scotland aired a documentary regarding Pfizer's blockbuster drug. I've included this documentary for your perusal.

It's in four parts and well worth watching:










Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING