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.

Australian Pharmacists Paid By Pfizer For Patient Details

The Sydney Morning Herald is reporting that Pfizer, one of the world's biggest drug companies, has been accused of paying Australian pharmacists to promote some of its best-selling drugs.

The Herald writes:

Pfizer pays pharmacies a $7 ''administration fee'' for each patient signed up to so-called support programs that involve the drug company providing information directly to patients about nine of its drugs.

Pharmacists say the deal, which Pfizer struck with the Pharmacy Guild of Australia in July, is similar to the one dumped this month for them to market dietary supplements with prescription medicines.

The pharmacists' union said it was another example of the owners' guild using the good name of pharmacists to boost its profits. The union called on the guild to abandon the deal.

One of the drugs included in the scheme is Pfizer's cholesterol-lowering blockbuster Lipitor, for which more than 10 million prescriptions were filled last year through the Pharmaceutical Benefits Scheme at a cost to the taxpayer of almost $600 million.

Pfizer will face competition from cheaper generic versions of the drug when its patent expires early next year.

Patients who sign up for the 12-week support program linked to Lipitor receive a cookbook and weekly emails containing health advice. Other Pfizer drugs with associated support programs are Champix, Xalatan, Viagra, Lyrica, Pristiq, Aricept, Celebrex and Effexor XR.

It's classic advertising by proxy and a cunning way to get around the ban on direct to consumer advertising that exists in Australia. Glaxo did the same back in 2002 with the marketing of Aropax [That's Seroxat and/or Paxil to you and I]. They kindly offered special counselling with the A Plus Project...on the proviso that the patient continued to take their medication, if they didn't then the offer of counseling was withdrawn. Great ethics, eh? [Source]

So, if you are an Australian and you have, in the past, used another pharmaceutical product for your erectile dysfunction, don't be surprised if you are sent some paraphernalia through the post that 'bigs up' [excuse the pun] Pfizer's products.

A Pfizer spokeswoman said the programs were designed to benefit patients rather than achieve commercial objectives.

''Under no circumstances does Pfizer market its medicines directly to patients,'' she said.

Yeh, and a cow just jumped over the moon!

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE
OR UK FROM CHIPMUNKA PUBLISHING

AUSTRALIAN ORDERS HERE

Seroxat Sufferers - Over 500

I'll be busy over the next week or so, many documents to trawl through that will take up most of my time.

Meantime, I offer readers a selection of posts from my blog that have had over 500 views.

Obviously, I can't post them all as I'd have to go back to 2006.

Anyway, see what tickles your fancy.


Ontario Government To Fund the Smoking Cessation Drugs Champix and Zyban [695 HITS]
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.


News 7: More Complaints Against Prof Graham Burrows [748 HITS]
Australian psychiatrist Graham Burrows remains tight-lipped on recent allegations that he over medicated patients and prescribed them psychiatric drugs after just spending 30 seconds with them.


2011 CCHR Human Rights Awards Banquet [868 HITS]
A gathering of like-minded people. A show of solidarity in the fight against the drugging of children. A feeling of an intense connection with those you meet.


HERE WE GO AGAIN - Viibryd, the new SSRi [569 HITS]
Just when you thought it was safe to go back to your doctor and not be presented with a new option of antidepressant medication.


DEAD WRONG - THE DOCUMENTARY - A REVIEW [1763 HITS]
The documentary, 'Dead Wrong' centres around a mother, Celeste Steubing, searching for answers as to why her son, Matthew, killed himself. The journey she embarks on reveals to her how dangerous the drug, Lexapro and other antidepressant medications can be.


VIAGRA TO BE SOLD IN TESCO STORES..."EVERY LITTLE HELPS." [589 HITS]
I can't turn on the radio these days without hearing adverts for erectile dysfunction, case in point being the offer of help from pharma giants Lilly. 40over40 website.


Glaxo, Children and Lucozade...Not made from Girders! [2510 HITS]
Oh how I remember as a kid I used to get the old sniffle. My dear old mother would make sure I was comfortable in bed, hot water bottle, a supply on tissues to wipe the running nose. There was something else too...


The Inquest of Sara Carlin and the Moderation of Yahoo Groups [847 HITS]
During the inquest of Sara Carlin, I strived to report to the best of my ability. Much of the mainstream reporting of this particular case came from Canada and I saw fit to report on issues that the mainstream media were ignoring. It's all documented on this blog. During the inquest, this blog's web traffic increased considerably, a good 80% of daily hits coming from all over Canada. What I didn't expect was the vile behaviour of my obsessive online critic, Jeremy Bryce. His constant goading on Yahoo Groups throughout the inquest shocked even me...


The GMC/GLAXO Email [611 HITS]
Following on from yesterday's article regarding Dr. Sarah Myhill who has fallen victim to the General Medical Council [GMC] As promised here is the entire email as discussed in that article...


I'll be back soon

Fid 

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING 

AUSTRALIAN ORDERS 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


ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING

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

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

Researchers Find No Clear Evidence of Self-Harm Risk From Antismoking Drug

I find this rather odd. It interests me as I have previously wrote about Chantix and Zyban. Be sure to watch the video documentary at the foot of this post.


Source: WebMD
Study: Chantix Has Little or No Suicide Risk

Oct. 1, 2009 -- The antismoking drug Chantix has been linked to suicide and suicidal thoughts, but a new study shows that if such a risk exists it is likely to be very small.

Researchers from the U.K.'s drug regulatory agency and the University of Bristol compared the incidence of suicide and self-harm among smokers taking Chantix to that of smokers using the drug Zyban or nicotine-replacement products to help them give up cigarettes.

Full story here

Here's where I have previously wrote about Chantix [Champix is UK name] and Zyban.


The SSRi Road To Hell by Bob Fiddaman

Passenger Safety - The Champix Scandal









Fid

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

SSRi's - "DO NOT STOP ABRUPTLY"

We are warned by the patient information leaflets and by the regulators to not stop SSRi treatment abruptly.

It would be nice if we had a choice!

Monday, 24 August 2009

Concerns over vital drugs shortage

Shortages of certain medicines is causing patients "extreme distress" and even seeing them admitted to hospital, pharmacists have warned.

Of more than 150 community pharmacies surveyed, nearly a third said patients had suffered because they had difficulty sourcing medicines including those for breast cancer, blood clots and anti-depressants.

One pharmacist reported that a patient had panic attacks waiting for the anti-depressant Cipralex, and another said the wait for the breast cancer drug Femara had caused "extreme distress".

In another case, a shortage of the blood clot drug Plavix had contributed to a hospital admission, it was claimed.

More HERE

Hat-Tip - Janice Simmons

Fid

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

The SSRi Road To Hell by Bob Fiddaman

I have previously wrote about Pfizer's anti-smoking [mind-warping] drug, Champix [Chantix in the US], where I had learned that both the Federal Aviation Administration [FAA] and the Civil Aviation Authority [CAA] had banned this particular drug for use in their pilots and Air Traffic Controllers [ATCO's].

It came as no surprise to me seeing as Champix can cause some pretty nasty side-effects, some that could basically turn those prescribed it into a raving lunatic.

It got me thinking. If Champix was banned for use in our pilots and ATCO's then what of other mind-altering drugs such as SSRi's?

It's two-fold really. Who would want to fly with 'Loony Airlines' whose pilots and ATCO's are drugged up on SSRi's? And being treated for an illness that needed SSRi's has to come into the equation too... unless of course they had been given an SSRi for premature ejaculation - no problem with a pilot who arrives to quickly in my book.

I wrote back to the CAA and also made a fresh request to the MHRA.

Have pilots and ATCO's been banned from taking Seroxat and other SSRi's?'

The answer is a resounding Yes. This from Jill Vening, Senior Aeromedical Adviser, CAA, Gatwick:

"Dear Mr Fiddaman,

Thank you for your e/mail query regarding Seroxat & pilots/ATCO's. I can confirm that the UK CAA does not permit this medication or any other of the SSRI group of drugs and psychotropic medication in general to be taken whilst holding a valid medical certificate. This is because of the side effect profile and the condition for which it has been prescribed."

Short and sweet but transparency at its best.

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

Passenger Safety - The Champix Scandal

Special thanks to Janice Simmons of the Seroxat User Group for bringing this to my attention.





What is Champix?

Pfizer's 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.

This article throws further speculation on Chantix.

"I had a feeling that once varenicline started to be widely prescribed, that patients might start reporting to their doctors that they felt less depressed,"says Marina Picciotto, a professor of psychiatry at Yale University.

Chantix is a partial agonist of the nicotinic acetylcholine receptors, which means that it both stimulates them and blocks them simultaneously — like cupping a hand over a button while pressing it gently.

"The potential of nicotinic partial agonists for treatment of depression has not been formally evaluated in humans, Says Tony George. "But, I think there is lots of evidence to speculate that such a mechanism might be therapeutic in depression at least as an adjunct to standard antidepressant treatments."



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.

In November 2007, the FDA began to receive reports of psychiatric problems associated with the medication. The FAA’s Federal Air Surgeon Fred Tilton said he was aware of the anecdotal information circulating about Chantix, but chose to rely on hard data as it became available. “There were indications, but no clear data,” he said. “We don't just act indiscriminately.”

When more conclusive data was published, Tilton's Office of Aerospace Medicine moved quickly in response. [Source]

On July 10, 2008, The Washington Times reported that the Department of Veterans Affairs watchdogs concluded that the department failed to alert veterans suffering from post-traumatic stress disorder in a timely manner to the dangers posed by a drug it was prescribing. That drug was Chantix.

The Food and Drug Administration [FDA] approved the Pfizer's drug for sale in 2006, and the FAA first approved Chantix for pilot and controller use in July 2007.


So what of the UK aviation authority - have they banned Champix? [Chantix]

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?

I contacted the relevant departments - as yet I have received no response. I hope Champix has been banned for use in drivers/operators of public transport, if it hasn't then it begs the question, why?


And what of Pfizer, the manufacturer of Chamtix? Here's the Patient Information Leaflet for Chantix [US].

WARNINGS

Neuropsychiatric Symptoms and Suicidality

Serious neuropsychiatric symptoms have been reported in patients being treated with CHANTIX (See Boxed Warning, PRECAUTIONS/Information for patients, and ADVERSE REACTIONS/Post-Marketing Experience). These post-marketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.

In the UK it is known, confusingly, as Champix. Here's the UK patient Information Leaflet

4. POSSIBLE SIDE EFFECTS

"There have been reports of heart attack, hallucinations, depression, suicidal thoughts and hypersensitivity reactions (such as swollen face or tongue) in patients attempting to quit smoking with CHAMPIX."

Hardly the strongest of warnings compared to the US Patient Information Leaflet is it?

In fact two lines stating that there have been reports would hardly deter a doctor from prescribing it.

The difference in the warnings is staggering:

US WARNING: Which is at the very top of the PIL [Fig1]



UK WARNING: Which is listed within the 'Uncommon side effects' section. [Fig2]



Quite a contrast. It makes one wonder if Champix should carry a government health warning the same way cigarettes do here in the UK. In fact images of lung cancer and other smoking related diseases now appear on packets of cigarettes - maybe Pfizer should add images of psychiatric instabilities to packs of Champix, then again, maybe they should just pull the thing off the shelves?

Finally, a documentary aired on 'BBC Scotland Investigates' - "Ashes to Ashes". I'm unsure when it was aired.

It's in four parts [part four just over an hour in length] and well worth watching:










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