Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, August 21, 2009

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].


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


"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:



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