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Healthy Living
Smoking Cessation Drug Linked to Serious Cardiovascular Disorders
Date: 07/07/11
Keywords: American Food and Drug Administration (FDA), Pfizer, Champix, Cardiovascular Health, Depression, Heart Disease, Smoking, Stroke
Recently, an international team of researchers called for Champix (generic name varenicline) to be banned, after research linked the drug to an increased risk of heart attack and stroke.
The researchers analyzed data from 14 clinical trials, involving 8,216 patients. They concluded that the drug was associated with a 72 per cent increased risk of hospitalization due to serious cardiovascular events, such as heart attack, arrhythmia or stroke. The findings were published in the Canadian Medical Association Journal.
Lead researcher Professor Curt D. Furberg, said, "We have known for many years that Chantix is one of the most harmful prescription drugs on the US market, based on the number of serious adverse effects reported to the FDA. It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events."
Nausea, constipation, gas, vomiting, changes in dreaming, diarrhoea, gingivitis, chest pain, back pain, dizziness, anxiety, depression, emotional disorder, polyuria (excessive urination), menstrual disorder, hypertension, suicidal ideation and violent behaviour.
That’s a pretty daunting list of side effects... especially if the only thing you want this drug to do, is help you stop smoking!
And the culprit is none other than Champix, Pfizer’s smoking cessation drug.
Devil on the loose
We first told you about Champix in the spring of 2006, just as Pfizer was preparing to launch this drug in the US (where it is known as Chantix). At that time, all systems were go based on long-term studies that found the drug to be effective for about 20 per cent of subjects, compared to only 16 per cent of subjects who used Zyban, another smoking cessation drug.
Since 2007, the American Food and Drug Administration (FDA) has been reviewing Champix’s safety, after receiving hundreds of reports of unpredictable, aggressive and suicidal behaviour following its use.
From May 2006 through to December 2007, the FDA received 227 domestic reports of suicidal acts, thoughts or behaviours, 397 cases of possible psychosis and 525 reports of hostility or aggression. These totals included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination.
Now you’d expect that the seriousness of these complaints would be enough reason for the FDA to ban Champix... But no. Instead, the FDA ordered Pfizer to add a strong "black box" warning in 2009 to highlight the risk of serious mental health problems Champix may cause.
In fact, in the UK too, it is still approved for use on the NHS with a recommendation to be prescribed ‘only as part of a programme of behavioural support’... and as always, Pfizer denies any allegations that a direct link exists between Champix and psychiatric problems. They reckon that since this link has not been established in clinical trials, there is no cause for concern...
Then again, we are all aware of the fact that Big Pharma often fails to report or publish the negative outcomes of their drug trials... and why would they, especially if they have a drug that can potentially rake in millions!
Risk of stroke and congestive heart failure
Since we last reported on Champix’s side effects, almost a year ago, not much has changed... It’s still on the market and the side effects are still causing misery for countless people.
Recently, an international team of researchers called for Champix (generic name varenicline) to be banned, after research linked the drug to an increased risk of heart attack and stroke.
The researchers analyzed data from 14 clinical trials, involving 8,216 patients. They concluded that the drug was associated with a 72 per cent increased risk of hospitalization due to serious cardiovascular events, such as heart attack, arrhythmia or stroke. The findings were published in the Canadian Medical Association Journal.
Lead researcher Professor Curt D. Furberg, said, "We have known for many years that Chantix is one of the most harmful prescription drugs on the US market, based on the number of serious adverse effects reported to the FDA. It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events."
As expected, Pfizer has expressed concerns about the reliability of the meta-analysis by the researchers and said in a statement that it stands behind the benefit/risk profile of Champix.
Personally, I can’t see any benefit in taking this drug...
Let’s face it, people who try to quit smoking do so because they want to improve their health (especially their heart health given the strong link between smoking and cardiovascular disease) and live longer. The last thing crossing their mind is that they will potentially end up with psychosis, suicidal thoughts, violent behaviour and an increased risk of having a heart attack or stroke, all because of a smoking cessation drug!
Champix: Related Reading:
Controversial Anti-Smoking Drug Makes Headlines Yet Again
Champix Side Effects – Dangers Of Popular Drug Used To Quit Smoking
Champix, a Slow-ticking Time Bomb
Sources:
‘Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibase.’, Drug Saf. 2007;30(6):515-25.
‘Muscle Pain and Weakness With Statin Treatment May Herald ALS’ published online 26.09.08, medscape.com/viewarticle/581113
‘Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials’ The Lancet, Volume 375, Issue 9716, Pages 735 - 742, 27 February 2010
‘Balancing the benefits of statins versus a new risk— diabetes’ The Lancet, Volume 375, Issue 9716, Pages 700 - 701, 27 February 2010
Back to topThat’s a pretty daunting list of side effects... especially if the only thing you want this drug to do, is help you stop smoking!
And the culprit is none other than Champix, Pfizer’s smoking cessation drug.
Devil on the loose
We first told you about Champix in the spring of 2006, just as Pfizer was preparing to launch this drug in the US (where it is known as Chantix). At that time, all systems were go based on long-term studies that found the drug to be effective for about 20 per cent of subjects, compared to only 16 per cent of subjects who used Zyban, another smoking cessation drug.
Since 2007, the American Food and Drug Administration (FDA) has been reviewing Champix’s safety, after receiving hundreds of reports of unpredictable, aggressive and suicidal behaviour following its use.
From May 2006 through to December 2007, the FDA received 227 domestic reports of suicidal acts, thoughts or behaviours, 397 cases of possible psychosis and 525 reports of hostility or aggression. These totals included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination.
Now you’d expect that the seriousness of these complaints would be enough reason for the FDA to ban Champix... But no. Instead, the FDA ordered Pfizer to add a strong "black box" warning in 2009 to highlight the risk of serious mental health problems Champix may cause.
In fact, in the UK too, it is still approved for use on the NHS with a recommendation to be prescribed ‘only as part of a programme of behavioural support’... and as always, Pfizer denies any allegations that a direct link exists between Champix and psychiatric problems. They reckon that since this link has not been established in clinical trials, there is no cause for concern...
Then again, we are all aware of the fact that Big Pharma often fails to report or publish the negative outcomes of their drug trials... and why would they, especially if they have a drug that can potentially rake in millions!
Risk of stroke and congestive heart failure
Since we last reported on Champix’s side effects, almost a year ago, not much has changed... It’s still on the market and the side effects are still causing misery for countless people.
Recently, an international team of researchers called for Champix (generic name varenicline) to be banned, after research linked the drug to an increased risk of heart attack and stroke.
The researchers analyzed data from 14 clinical trials, involving 8,216 patients. They concluded that the drug was associated with a 72 per cent increased risk of hospitalization due to serious cardiovascular events, such as heart attack, arrhythmia or stroke. The findings were published in the Canadian Medical Association Journal.
Lead researcher Professor Curt D. Furberg, said, "We have known for many years that Chantix is one of the most harmful prescription drugs on the US market, based on the number of serious adverse effects reported to the FDA. It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events."
As expected, Pfizer has expressed concerns about the reliability of the meta-analysis by the researchers and said in a statement that it stands behind the benefit/risk profile of Champix.
Personally, I can’t see any benefit in taking this drug...
Let’s face it, people who try to quit smoking do so because they want to improve their health (especially their heart health given the strong link between smoking and cardiovascular disease) and live longer. The last thing crossing their mind is that they will potentially end up with psychosis, suicidal thoughts, violent behaviour and an increased risk of having a heart attack or stroke, all because of a smoking cessation drug!
Champix: Related Reading:
Controversial Anti-Smoking Drug Makes Headlines Yet Again
Champix Side Effects – Dangers Of Popular Drug Used To Quit Smoking
Champix, a Slow-ticking Time Bomb
Sources:
‘Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibase.’, Drug Saf. 2007;30(6):515-25.
‘Muscle Pain and Weakness With Statin Treatment May Herald ALS’ published online 26.09.08, medscape.com/viewarticle/581113
‘Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials’ The Lancet, Volume 375, Issue 9716, Pages 735 - 742, 27 February 2010
‘Balancing the benefits of statins versus a new risk— diabetes’ The Lancet, Volume 375, Issue 9716, Pages 700 - 701, 27 February 2010
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