Champix and the heart

A number of media stories concern reports that Champix may be responsible for an elevated risk of heart attacks. The Mail, the Express, the Independent, Medical News Today and others including the Scotsman all carry the story. The increased risk is said to be 72 per cent, which while being around three times greater than the alleged risk of secondary smoke exposure causing lung cancer or heart disease is still not conclusive.

Alone among these stories, the Scotsman makes no mention of the injuries associated with Champix. Not everyone is affected by them, but many disturbing after-effects have been reported, some of which have led to suicide – enough to make many users and their friends call for the drug to be banned.  There are also reports that adverse incidents were reported through 'improper channels' (and here) in order to cover them up.

Study author Singh said: "I think our new research shifts the risk–benefit profile of varenicline. People should be concerned. They don't need Chantix to quit and this is another reason to consider avoiding Chantix altogether." Champix's history has been enough to get the drug withdrawn in France. It didn't need an inconclusive study on heart troubles to conclude that Champix could well be more trouble than it's worth.

Interestingly Medical News Today also states this:

Varenicline has been shown to modestly increase the chances of a successful quit attempt, compared to unassisted smoking cessation attempts. But overall, the majority of smokers who quit do so without any pharmaceutical assistance at all.

Surely this is a cue for a stop to ridiculous claims like this? and thousands of pounds of public money poured into smoking cessation aids, when most quitters don't need them.

Nicotine receptors in the brain: Of Champix and vaccines

As the scale of the radiation disaster in Japan becomes clear we learn that a nicotine vaccine is on the way. Just what the doctor ordered.

Comparisons with Champix should raise alarm bells (see link from Dick Puddlecote's post). Champix works by attaching itself to and blocking nicotine receptors in the brain. As a side effect, it can also block serotonin receptors in the brain, as described here by lawyers involved in Champix litigation. Champix has been banned for use by pilots for many years now. The risk of adverse consequences is very well known.

Much as I distrust antis, I can't go along with the idea that they have produced a drug that would block smokers from experiencing any pleasure at all. Even although some people find it hard to believe it, parts of the brain do respond to nicotine specifically, and it is these receptors that the manufacturers of Champix have attempted to block.

Smokers are, however, expected to accept a fair risk that they will react badly to Champix. And that doesn't just mean a sore head. If you're unlucky, the Champix blocks your seratonin receptors too:

Varenicline, the active ingredient of Chantix, has only one significant side effect: it also has an affinity for the 5-HT3 serotonin receptor. If the varenicline binds to this serotonin receptor, the serotonin response, like the nicotine response, is inhibited. Serotonin regulates several stress hormones, so an inhibition of serotonin reception can lead to side effects like nausea, headaches, anxiety disorders, and changes in libido and appetite, similar to side effects seen for SSRI antidepressants.

There is no shortage of warnings and stories on the internet on this drug.

ASH Scotland, perhaps uniquely, tells us 'there is emerging evidence that varenicline is safe and effective for people with mental health problems'. Not by my definition of the word 'safe', there isn't.

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.