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.

Ontario Government To Fund the Smoking Cessation Drugs Champix and Zyban

In what can only be described as a sheer act of lunacy, the Ontario government have decided that they will fund the smoking cessation drugs Champix and Zyban by adding them to the Ontario Drug Benefit Plan.

Health Minister, Deb Matthews

"The list of medications covered by the province could cost between $10 million to $15 million a year", said Health Minister Deb Matthews in an article on healthzone.ca

Back in June, the FDA, the American food and drug regulator, issued a warning regarding Pfizer's Chantix, known as Champix in the UK. "FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease."

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.

It's great to see that the Canadian Health Minister really has her finger on the pulse. FDA release a warning that a drug can increase cardiovascular adverse events, the Canadian government decide to add the very same drug to the Ontario Drug Benefit Plan, thus making it easily affordable to people on low income. Way to go Canada!

Glaxo's Zyban, which is basically Wellbutrin [SSRi] rebadged, is classified as a Category C medicine by the FDA, meaning that it could potentially cause harm to your unborn child.

More info on Champix/Chantix:

58 Page document from the Federal Aviation Administration

Dying for a Pfizer Pfag [Chantix]

Passenger Safety - The Champix Scandal

IF SMOKING DON'T KILL YOU... LET CHANTIX DO THE JOB

The FDA have just released a safety update regarding the anti-smoking drug Chantix, known as Champix in the UK.

FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease.

FDA release HERE

This has prompted some great advertising slogans for Chantix.

"Smoking Kills, Chantix Kills better"

"Quit smoking with Chantix - why wait for lung cancer when a heart attack is quicker and a more humane death"

"Smoke or stroke?"

I hear Abba are reforming and will be releasing a new revamped version of their 1978 classic, "Take a Chantix On Me." A tour will commence which will see the Swedish quartet throw packets of empty cigarettes and Chantix to their audience.

Can you come up with the perfect slogan for Chantix?


Special thanks to Stan for some amusing slogans.

Fid


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Dying for a Pfizer Pfag [Chantix]

Pharmaceutical giants Pfizer have hit the news...but not in the way they would like. Their anti-smoking cessation drug, Chantix, also known as Champix, is the subject of data being submitted through “improper channels” with regard to its safety and side effects.

Some 150 suicides, more than doubling those previously known, were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices, writes JoNel Aleccia, a health writer for msnbc.com.

This should come as no surprise for those that write about the pharmaceutical industry and the poor way in which prescription medication is regulated by the powers that be.

In 2008 the Federal Aviation Administration [FAA] took the unusual step of banning the use of varenicline [Champix] after it learned the anti-smoking medicine might lead to safety problems, it ordered pilots and air traffic controllers to stop taking it immediately. Strangely it is called Chantix in the USA.

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 FAA responded to my FOI in which I had requested the following:

1. Request for minutes of meetings where the change in the policy was on the agenda. List of members present and a declaration of interests of each of the members.

2. Any information given to FAA from outside parties that relate to the FAA'S recent change in policy regarding pilots on antidepressant medication.

3. A list of SSRi medications that pilots are NOT permitted to use and reasons why you think these SSRi's still pose a threat to safety.

4. A list of anti-smoking cessation drugs that pilots are NOT permitted to use and reasons why you think these still pose a threat to safety.

5. Does the FAA's new policy extend to air traffic controllers, if not, why?

6. An official statement from your CEO that categorically states that the FAA envisage that there will never be any incidents in the future with pilots that can be traced back to any adverse drug reaction from Prozac, Zoloft, Celexa and Lexapro.

Here's the cover letter of their response to me:

Mr. Bob Fiddaman,
Quinton
Birmingham
UK

Dear Mr. Fiddaman,

Re: Freedom of Iformation Act (FOIA) request 10-4122

This responds to your Freedom of Information Act email inquiry of April 6,2010 containing six requests concerning the FAA's recent change in policy regarding pilots being treated with certain select antidepressant medications. The FAA's policy regarding pilots with depression taking antidepressant medication may be found in the U.S. Federal Register Notice of April 5,2010 attached.

1. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. This office located a Memorandum report of a consultants meeting regarding the proposed policy. A copy of this Memorandum is attached. There are no other records respondent to your request.

2. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. This offrce located information received from the Aerospace Medical Association, the Airline Pilots Association Aeromedical Office, the International Airline Pilots Association, and the United States Army. Copies of these documents are attached. In developing the new policy, the FAA also utilized a variety of medical research literature available in the public domain. We used internet sites such as, but not limited to: The National Library of Medicine PubMed site and the FDA Medwatch.

3. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The four SSRI medications that will be considered for possible special issuance medical certifrcation are listed in the U.S. Federal Register Notice of April 5, 2010 attached.

4. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The only anti-smoking drug permitted for use while flying is nicotine in the form of gum or skin patches. All others are not allowed.

5. A records search was conducted at FAA Headquarters - Office of Aerospace Medicine. There are no records responsive to this request. The FAAs new policy does not presently apply to Air Traffic Control Specialist (ATCS) because the administrative details of the monitoring and follow-up of these employees are yet to be determined. The plan is that ATCSs will eventually be included in a program of this type.

6. This request does not apply under the Freedom of Information Act.

If you owe fees for the processing of this request, an invoice containing the amount due and payment instructions will be enclosed.

The accompanying 58 page document can be viewed HERE

This startling revelation by the FAA was obviously too much for me to handle so I sent the complete document along to investigative journalist, Evelyn Pringle. She, as with everything she writes, did it justice with an eye-opening article entitled, "SSRIs Render Unfriendly Skies"

One has to start asking questions regarding Pfizer's anti-smoking cessation drug. If the FAA deem it unacceptable for pilots to take this medication whilst operation an aircraft then they are sending out a crystal clear message - This drug is dangerous!

My only surprise is that the likes of Patrick McGorry, the Australian psychiatrist who plans to diagnose children as young as three for mental disorders they may get in the future, hasn't picked up on this particular cash-cow. Hey, Paddy, why not screen kids to see if they will smoke in the future? You could always nip it in the bud with a course of Pfizer's Champix.

The article from JoNel Aleccia, 'Smoking-pill suicides overlooked in missing reports', can be read in full HERE.

Pfizer has some questions to answer - don't hold your breath folks.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

US/CANADA COPIES HERE 
UK/IRELAND FROM CHIPMUNKA PUBLISHING 

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

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