Sunday, 19 December 2010

ASH Scotland gives mixed message on Champix

ASH Scotland's latest media briefing on Champix (also Chantix or varenicline) states in its opening series of bullet points: 'there is emerging evidence that varenicline is safe and effective for people with mental health problems'.
A review of the evidence in Expert Opinion on Drug Safety[26] has concluded that although the risk of potential neuropsychiatric events is evident through voluntary reporting systems and reported cases in the literature, multiple studies and case reports support the use of varenicline in the mental health population.
The referenced study supporting the paragraph says (abstract): 'Cautious treatment initiation, patient education, and close follow-up, monitoring for mood and behavior changes during therapy are recommended, especially in the psychiatric setting'. It also says:
Although the risk of potential neuropsychiatric events is evident through voluntary reporting systems and reported cases in the literature, multiple studies and case reports support the use of varenicline in the mental health population.  
I have no idea of the rate of successful outcomes compared with adverse events. It is clear however that not only those with a history of mental illness or psychological problems suffer from the side-effects of taking Champix – a fact clearly acknowledged by ASH Scotland in its page featuring Champix:
However depression, suicidal thoughts, suicide attempts and completed suicides have been reported in patients taking varenicline who have no known pre-existing psychiatric conditions, and in patients who continue to smoke.
This page gives a clear message in bold type that anyone experiencing side-effects should stop using the drug and get medical help without delay. The confusing part is how this squares with the idea that Champix is 'safe and effective for people with mental health problems'. It would have taken very little to add 'on the understanding that the patient is carefully monitored, and it is not recommended as a treatment of first resort'.

Plaintiffs in court cases on Champix claim that Pfizer 'neglected to test Chantix adequately before its release, deliberately hid evidence of serious side effects and failed to sufficiently warn consumers about its risks'. There was no thorough testing of the drug on people with psychiatric problems, and this incomplete testing has become an issue as more reports of adverse reactions emerged over the years. (Neither of the users of Champix featured in this link had a history of serious mental health problems. One user took her life and the other experienced psychological disturbance following a twelve-week course, that led to a suicide attempt.)

The sheer bloody unpleasantness of taking something that completely unbalances you can't be stated too strongly: even without leading to suicide, it is not easy to put such an experience behind you. (I had an averse reaction to myself to a natural thyroid hormone: after three days on a minute dose I was ready to throw heavy things out of windows. I have been angry before but this was well beyond any previous experience. And the doctor who prescribed it for me found it hard to believe.) There are more stories here from people who wanted to make their stories public.

I can't help but think that ASH Scotland views people who experience such effects as unfortunate statistics – collateral damage in the war on smoking. They've made the warning clear on their website, but still find it easy to call the drug 'safe' for users of mental health services.


Anonymous said...

. By mid-2009, the U.S. Food and Drug Administration had received reports of nearly 100 suicides, 200 attempted suicides and close to 5,000 serious psychiatric events overall. Hundreds of reports of side effects have continued to stream in this year.

Anonymous said...

It would seem that most of what ASH puts out is misleading, could it be that they are all on Champix.


Dave Allison said...

I was on Champix for two weeks.
Ended up very very very depressed.
Filled in Yellow Card at doctors.

Anonymous said...

I have a little theory about Champix, which also ties in with a theory which I've had about smoking for some while.

It’s a known fact that smoking stimulates the development of certain brain cells (the ones described by the makers of a certain brand of NRT as wicked “nicotine receptors” in order to flog more of their products). But I think that they are more than just “nicotine receptors” – I think they are more generalised “pleasure receptors” i.e. they enable an individual to be more keenly aware of any pleasurable experiences in life – of which smoking is just one. It explains a lot to me in terms of why smokers, despite all the persecution and victimisation that they face today, are almost always more positive, cheerful, open-minded and better company than their non-smoking counterparts. Don’t get me wrong – I’m not saying for one second that all non-smokers are miserable old gits who sit around moaning (that’s just anti-smokers), but what I’m saying is that even positive, happy non-smokers would be even more positive and happy if they smoked, because they’d have a greater capacity to enjoy both the large and small good things in life and to overlook or accept the not-so-good ones.

Now, as the manufacturers proudly announce, and as doctors are always keen to tell prospective “quitters” – albeit in a rather vague and generalised way - Champix is a drug which works by “switching off” those so-called “nicotine receptors” and thus rendering smoking no longer an enjoyable activity. But what if, by “switching off” those “nicotine receptors,” what Champix actually did was switch off a person’s capacity to enjoy any of the things which they used to feel pleasure and get satisfaction from? Well, I would imagine that pretty quickly they’d start to experience the kind of negative reactions illustrated in the stories linked here – irritability, anger, frustration, aggression. I mean, can you imagine not being able to get pleasure from anything; from only ever being able to experience the negative sides of life – the frustrations, the irritants, the hassles, the “downsides?” It therefore makes a lot of sense that so many of the people in these stories describe themselves as previously “happy go lucky” or “positive” or “easy going.” It would also explain much as to why so many of the problems occur in people who previously haven’t experienced any mental problems – those who have had to cope with depression or anxiety or panic attacks may well be used to feeling negative or afraid about the world and to coping with it, or indeed they may already be on medication which negates these effects, and thus also negates the effects of the Champix.

It would be interesting to hear from any sufferers of Champix’s side effects – given their long term and seemingly permanent nature – whether beginning smoking again (thus stimulating the re-growth of those “pleasure receptors” in the brain) has ever been effective in reversing them. Now, wouldn’t that be interesting …..?

Belinda said...

Thanks Anonymous. What you say reminds me of some of my problems before I found a dose of thyroxin that suited me. On too high a dose I found that I ceased to expect to get pleasure from anything, but once I realised what was wrong it was easy to correct.

I have no idea whether the damaged caused by Champix can be reversed simply by smoking or otherwise stimulating the receptors, but it would be interesting to hear of any direct experience of this.

snore stop said...

Hundreds of reports of side effects have continued to stream in this year.