Now, on Ground Hog Day (2-2-08), surfacing from underground as if looking for a way to hide from this shadow, Chantix gets another blow.
I certainly believe that this new process at the FDA, what I refer to as 'faster track' because drug companies pay more than before to hurry their drug to market WITHOUT PROPER TESTING!, does nothing to protect the public. And you can blame Congress for this as it was their short sighted action that saw PAC $$$ as the prize, not public health and safety.
If you are looking for safe ways to stop smoking let us know as we can provide you with information about more sensible ways to stop smoking.
FDA warns about Pfizer anti-smoking drug By Kim Dixon, Fri Feb 1, 08
Pfizer Inc's anti-smoking drug Chantix appears increasingly likely to be linked to serious psychiatric behavior, including suicide, U.S. regulators said on Friday.
The Food and Drug Administration (FDA) said that after an analysis of cases of depression, suicidal thoughts and other unusual behavior in patients on the medication, the evidence appears stronger of an association with Chantix.
"We've become increasingly concerned as we've seen there are a number of compelling cases that truly look as if they are the result of exposure to the drug," Bob Rappaport, a director in FDA's unit that oversees Chantix, told reporters on a conference call.
Pfizer, the world's biggest drugmaker, had already updated its label to reflect the latest findings. Earlier this month it changed the label to more prominently warn that patients taking Chantix have experienced suicidal thoughts and other psychiatric behavior.
FDA officials said on Friday they had asked Pfizer to make that change.
The agency also said there was rising evidence of a causal link, an assertion Pfizer has denied.
Some cases "strongly appear to be related" to Chantix, Rappaport said.
Pfizer officials have maintained there is no evidence of a causal link, and said only that in some cases an association could not be excluded. The reports could also be confounded by symptoms of nicotine withdrawal itself, Pfizer has said.
"A causal relationship has not been established. At the same time, we can't exclude it," Ponni Subbiah, Pfizer vice president for medical affairs, said in an interview on Friday.
FDA officials said they have received nearly 500 reports of suicidal behavior and thinking, and 39 completed suicides. Most of these cases occurred in the United States.
About 4 million people in the United States have used the drug since its 2006 approval. Chantix had sales of $280 million in the fourth quarter of 2007.
FDA officials said they would continue their analysis, calling it an evolving issue.
Under rising scrutiny about drugs' safety risks, the FDA has in recent months begun alerting the public earlier when it spots potential safety issues.
The FDA in November issued an "early communication" on Chantix, saying it would analyze reports of suicidal thoughts and other unusual behavior.
Chantix works by tinkering with molecules in the brain to produce some of the pleasing effects of nicotine to ease withdrawal symptoms.
The FDA said the drug is effective but that patients should talk to their doctors about this new safety information. Patients should report to doctors any history of mental illness and be alert to changes in behavior.
(Reporting by Kim Dixon, Editing by Carol Bishopric, Toni Reinhold)
Copyright © 2008 Reuters Limited.
Last updated at 12:33pm on 21st January 2008
Now several days have passed and more news is out regarding the dangers of Chantix -
however, there are other older medical treatments and safe, natural remedies to help you achieve your goal of stopping the tobacco habit.
Widow claims father-of-two was driven to suicide by 'quit smoking' drug
A widow claimed yesterday that a drug designed to help smokers quit may have played a role in her husband's suicide.
Father-of-two Wayne Marshall, 36, was found hanged shortly after completing a 13-week course of Champix, which it is feared may have depressive side effects.
His death is the second in the UK to be linked to the newly-licensed drug.
Mr Marshall's widow Emma said he was prescribed the drug by his GP last August to help him quit his 20-a-day habit, but quickly went downhill, cutting himself off from his family and friends.
Father-of-two Wayne Marshall, 36, was found hanged shortly after completing a 13-week course of Champix, which it is feared may have depressive side effects
Mr Marshall, a welder, from Rossington near Doncaster, died in November. Last month, an inquest in Doncaster recorded a verdict that he killed himself.
Mrs Marshall, 28, said she believed the drug had played a part in his death and has reported the case to the Medicines and Healthcare Products Regulatory Agency.
"I don't want anybody to go through what myself, his children and his family and friends are facing," she said. "It is horrendous.
"People need to think about going on this drug, particularly if they have a history of depression.'
After her husband's inquest, Mrs Marshall, a distribution coordinator, discovered Champix has been linked to depression.
Mrs Marshall, who said her husband had once before attempted suicide when he was a teenager, had moved out of the couple's home a month before the tragedy.
His previous attempts to give up smoking had failed, but he did not smoke while taking Champix. He became quiet and withdrawn, however, and one day she found him sobbing uncontrollably.
"I don't understand how he went downhill so quickly," she said. "He was not the type of person who needed picking up but his whole personality changed. He closed himself off completely from everybody.
"These tablets did seem to be working. It was just his moods."
He had finished the drug course a week before she last saw him, but had started smoking immediately.
"He was more positive than when I saw him previously," she said. "Never ever could I have dreamt he would have done something like that."
Last October, TV editor Omer Jama, 39,was found dead at his home in Bolton.
He slashed his wrists weeks after starting a course of Champix. Mr Jama had just booked a foreign holiday and had no history of depression.
The European Medicines Agency last month ordered improved warnings to patients over the twice-daily prescription medicine following reports it could lead to depression.
Figures from the MHRA show one patient has taken his life while on the drug, two others have attempted suicide and there have been 60 other "suicidal-type suspected adverse reactions" reported.
About 200,000 patients have been prescribed the drug in the UK since December 2006 and it was approved by the Health Service last July.
An MHRA spokesman said Champix, which is made by Pfizer, was being closely monitored. He said: "Giving up smoking can be very stressful. The side effects are suspected. It does not necessarily mean the drugs caused the reaction."
Originally posted 1/1/08:
Art Bell fell for the dangers of Chantix
Last night I was listening to Art Bell who raved about the wonders of Chantix in helping him stop smoking. Art Bell is known to be a pharmaceutical MSM type of guy, and I am sure his comments, without any opposing view will drive many of his listeners down to the corner doctor to get this drug. New Year type resolution thing you know!
For those who don't know, the smoking habit and nicotine overload along with additive chemicals plied into cigarettes by the tobacco industry, withdrawing from tobacco habits is as or more difficult than heroin withdrawal. My experience in chemical dependency treatment has shown me that heroin withdrawal is a very horrible situation. Helping people get off tobacco is pretty tough as well.
The chemistry of this latest synthetic chemical drug might make it addictive. I would be very cautious, just based on the fact that there are NO longterm studies.
I also wonder about the interference with acetylcholine and its role in nerve transmission.
CHANTIX® tablets contain the active ingredient, varenicline (as the tartrate salt), which is a partial agonist selective for a4b2 nicotinic acetylcholine receptor subtypes.Wonder drug for smokers linked to seven deaths in Britain
Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H- pyrazino[2,3- h]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water.
Not for those with renal problems -
Varenicline is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
By RACHEL ELLIS, Daily Mail (UK)
30th December 2007
More than 1,300 people who have used the drug Champix and have reported possible side effects
A new anti-smoking 'wonder drug' taken by nearly a quarter of a million Britons is feared to be linked to the deaths of seven people.
Their cases are included in a dossier featuring more than 1,300 people who have used the drug Champix and have reported possible side effects, ranging from headaches, nausea and vomiting to heart disorders and suicidal thoughts.
When Champix was launched a year ago it was hailed as the most effective weapon in the fight to give up smoking.
In trials, 22.5 per cent of quitters who took the prescription-only drug were still not smoking after a year, compared with 16 per cent of people who used nicotine-replacement therapy and just three per cent who attempted to stop by using willpower alone.
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The non-nicotine product works on brain receptors to relieve the cravings and withdrawal symptoms associated with quitting.
Pfizer, the manufacturers of Champix, maintain there is no evidence the drug has dangerous side effects. But the Government's medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), has received numerous reports of possible problems.
Earlier this month, the European Medicines Agency ordered a safety warning to be included in the drug's patient information, saying that any Champix users who develop suicidal thoughts should stop their treatment and contact their doctor.
Last night, the MHRA said it was 'monitoring the emerging safety information concerning Champix'.
The seven suspicious deaths – reported to the MHRA by doctors, nurses and patients – were attributed in two cases to heart problems and in one case to vascular disorder. A further three were put down to 'general health problems'. The other reported case was the suicide of 39-year-old Omer Jama, an editor at Sky TV, who slashed his wrists weeks after starting a course of the pills.
Last night, Dr John Griffin, the ex-editor of the medical journal Adverse Drug Reactions, who has been an expert in the safety of medicines for more than 35 years, said: 'Some anti-smoking remedies contain a substance which also has anti-depressant actions. A number of anti-depressants have an effect that causes people who want to commit suicide to do so.
'Any drug with a propensity to increase suicide risk has to be treated very seriously.'
The MHRA figures show that up to December 18 there were 1,335 reports of UK patients taking Champix suffering suspected adverse reactions. Some patients experienced several problems.
The most common reactions were psychiatric problems (748 cases), gastrointestinal disorders (819), nervous-system disorders (511) and heart disorders (70).
In the US, where the drug has been taken by four million people, there were 5,157 complaints about it in just one week – 55 of which involved suicides and 199 suicidal thoughts – and an investigation into the drug was launched.
A spokesman for Pfizer said: 'There is no scientific evidence establishing a causal relationship between varenicline [the active ingredient in Champix] and these reported events. Patient safety is our priority.'
• Omer was 'spaced out' on pills...then he killed himself
Omer Jama was trying to beat a 15-year, 20-a-day smoking habit when he slashed his wrists in October.
The 39-year-old TV editor from Bolton had been taking Champix tablets for four weeks. His family say he had no history of depression and think the drugs may have affected his mental health.
He had split from his wife, but his brother Ali, 41, said: 'He had so much to live for. I thought about the pills straight away.'
Mr Omer's friend Gary Tonge, 39, said his girlfriend suffered irrational behaviour for four weeks while on Champix. 'One minute she'd be crying her eyes out, the next she'd be aggressive so I took the tablets off her and she was back to normal within a week,' he said.
'I asked Omer if he was OK. He said the tablets were making him feel a bit spaced out but he was determined to give up.'
Have you ever suffered side effects from using anti-smoking drugs?
You can check Chantix side effects at rxlist.com in case the doctor never took the time to explain as they are required by law to do.
Safe ways to help you stop smoking naturally are available from our office.