High suicide rates related Chantix were 'left out of crucial safety review

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High suicide rates related to anti-smoking drug Chantix were 'left out of crucial safety review'

By Daily Mail Reporter

Last updated at 4:43 AM on 28th May 2011

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Hundreds of reports of suicides and violent reactions tied to the stop-smoking drug Chantix were left out of a crucial government safety review.

The reports were missing because the drugs manufacturer Pfizer Inc. submitted years of data through 'improper channels', according to the Food and Drug Administration.

Serious problems such as people killing themselves, trying to kill themselves, depression and unprovoked attacks on others were mixed among 26,000 records of non-serious side effects such as nausea and rashes dating back to 2006, the year Chantix, or varenicline, was approved.

Controversial chemicals: Chantix is regarded as one of the 'riskiest' drugs by some scientists

Cases of 150 suicides, more than doubling those previously known, were among 589 delayed reports of severe issues uncovered in new analysis by the Institute for Safe Medication Practices (ISMP).

J , the senior scientist who analysed the data for the non-profit ISMP, said: 'Its really chilling. This seems to unleash something in people. It can be violence to anything around. Weve had a major breakdown in safety surveillance.'

His analysis echoes previous horror stories that Chantix can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and violent outbursts.

Federal Food and Drug Administration officials said that they asked Pfizer to resubmit thousands of records after realising that the company was sending required reports in an inappropriate format that could not be added to the agencys Adverse Events Reporting System, or AERS.

The agency said: 'Last year, the FDA became aware that a few manufacturers were submitting adverse events reports to FDA through improper channels.'

Extreme reactions: Approved in 2006, Chantix has been dogged by stories of unprovoked violencePfizer officials said they were submitting reports as required and that when the FDA asked them to change, they did so immediately. But they added that there's no proof that Chantix causes suicide or other serious side effects.

Mr , who has served as an expert witness in court cases related to Chantix, said it is the riskiest drug among those analysed from the FDA's adverse event reports, msnbc.com reports.

In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said.

, who has served as an expert witness in court regarding Chantix, said it's the riskiest drug among those analysed from the FDA's adverse event reports.

In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said.

WOMAN HIT SLEEPING LOVER FOR NO REASON

Scientist , who has studied Chantix, reported cases that describe 'inexplicable' reactions in patients, including:

A 24-year-old woman who started beating her boyfriend in bed because 'he looked so peaceful' and later attempted suicide.

A 42-year-old man who punched a stranger at a bowling alley.

A 47-year-old woman who died after she came out of a room, yelled at her daughters and then shot herself.

MURDER-SUICIDE OF CHANTIX RAGE HUSBAND

M Wain, 34, of Beaver County, Pennsylvania, shot himself and his wife, , 33, in May 2009 in what a lawyer for their families claims was a Chantix-fuelled rage.

Victor H. Prebanic, who represents the fathers of the slain couple, said: 'If the FDA had more information about suicides and other side effects tied to Chantix, the agency might have taken stronger action sooner. If Pfizer had been more forthcoming, the black box warning might have emerged earlier.

'For all we know, the drug would not have been available.'

FDA officials said the new reports did not change the agencys position on the risks and benefits of the controversial drug, which received a black box warning that included suicide the strongest caution possible in 2009.

Agency officials said they are continuing to review Chantix in clinical trials.

But Mr said the new data should raise immediate alarms about the drug that was prescribed 3.2 million times last year to people trying to stop smoking and 1.1 million times already this year.

He said: 'To us, it raises questions about whether this drug is safe for widespread clinical use.'

Pfizer officials said that the firm was following the FDA's rules and changed their reporting process once the agency asked for clarification.

Standing by its product: Despite the controversy, Pfizer continues to say there's no proof that taking Chantix can lead to suicide

The company said: 'All post-marketing reports of adverse events are reviewed by Pfizer and reported to regulators, including FDA, in accordance with regulatory guidelines.

'Pfizer takes patient safety and regulatory reporting obligations very seriously.'

The FDA requires drugmakers to submit adverse events in two ways.Theres an 'expedited' system that requires companies to report serious and unexpected adverse events into the AERS system within 15 days.

Then there's the less-serious and expected adverse events to be submitted quarterly in so-called 'periodic reports.'

In those cases, problems previously included on drug labels including suicide and suicide attempts are considered to be expected events.

In Pfizers case, the firm was submitting the periodic reports as required, but combining summaries and individual case reports in a single text file, the FDA said.

That meant that the individual reports of injury were not logged in the FDAs AERS system, drastically reducing known reports of suicides and other psychiatric problems tied to Chantix, Mr said.

He said: 'Its very clear the suicide risk of this drug was higher than we knew.'

Overall, there were 1,055 reports of serious problems with Chantix reported in the third quarter of 2010, more than any other prescription medication regularly monitored by the drug safety agency, Mr added.

Before last July, the FDA had logged 122 reports of suicides linked to Chantix, including 37 reported by Pfizer and 85 reported by health professionals or consumers.

After the 150 new Pfizer reports were added, the total jumped to 272.

In addition, the 589 new reports of severe problems included 102 cases of possible hostility and aggression, 156 cases of depression and 56 cases of possible psychosis.

Those were mixed among the 26,000 reports of less-serious problems.

Mr has asked the FDA to investigate the 150 new suicide reports, particularly if the events occurred before the 2009 black box warning listed suicide as a possible side effect.

FDA officials said they are considering changing regulations to allow expedited reports of suicides and other serious problems, even if theyve previously been identified as expected. Read more: http://www.dailymail.co.uk/health/article-1391774/Suicide-horror-smoking-drug-Chantix-fatality-reports-left-safety-review.html#ixzz1NjBXwvdQ

[Guest guest]

High suicide rates related to anti-smoking drug Chantix were 'left out of crucial safety review'

By Daily Mail Reporter

Last updated at 4:43 AM on 28th May 2011

http://www.facebook.com/2008/fbml" />

Comments (6)

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Hundreds of reports of suicides and violent reactions tied to the stop-smoking drug Chantix were left out of a crucial government safety review.

The reports were missing because the drugs manufacturer Pfizer Inc. submitted years of data through 'improper channels', according to the Food and Drug Administration.

Serious problems such as people killing themselves, trying to kill themselves, depression and unprovoked attacks on others were mixed among 26,000 records of non-serious side effects such as nausea and rashes dating back to 2006, the year Chantix, or varenicline, was approved.

Controversial chemicals: Chantix is regarded as one of the 'riskiest' drugs by some scientists

Cases of 150 suicides, more than doubling those previously known, were among 589 delayed reports of severe issues uncovered in new analysis by the Institute for Safe Medication Practices (ISMP).

J , the senior scientist who analysed the data for the non-profit ISMP, said: 'Its really chilling. This seems to unleash something in people. It can be violence to anything around. Weve had a major breakdown in safety surveillance.'

His analysis echoes previous horror stories that Chantix can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and violent outbursts.

Federal Food and Drug Administration officials said that they asked Pfizer to resubmit thousands of records after realising that the company was sending required reports in an inappropriate format that could not be added to the agencys Adverse Events Reporting System, or AERS.

The agency said: 'Last year, the FDA became aware that a few manufacturers were submitting adverse events reports to FDA through improper channels.'

Extreme reactions: Approved in 2006, Chantix has been dogged by stories of unprovoked violencePfizer officials said they were submitting reports as required and that when the FDA asked them to change, they did so immediately. But they added that there's no proof that Chantix causes suicide or other serious side effects.

Mr , who has served as an expert witness in court cases related to Chantix, said it is the riskiest drug among those analysed from the FDA's adverse event reports, msnbc.com reports.

In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said.

, who has served as an expert witness in court regarding Chantix, said it's the riskiest drug among those analysed from the FDA's adverse event reports.

In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said.

WOMAN HIT SLEEPING LOVER FOR NO REASON

Scientist , who has studied Chantix, reported cases that describe 'inexplicable' reactions in patients, including:

A 24-year-old woman who started beating her boyfriend in bed because 'he looked so peaceful' and later attempted suicide.

A 42-year-old man who punched a stranger at a bowling alley.

A 47-year-old woman who died after she came out of a room, yelled at her daughters and then shot herself.

MURDER-SUICIDE OF CHANTIX RAGE HUSBAND

M Wain, 34, of Beaver County, Pennsylvania, shot himself and his wife, , 33, in May 2009 in what a lawyer for their families claims was a Chantix-fuelled rage.

Victor H. Prebanic, who represents the fathers of the slain couple, said: 'If the FDA had more information about suicides and other side effects tied to Chantix, the agency might have taken stronger action sooner. If Pfizer had been more forthcoming, the black box warning might have emerged earlier.

'For all we know, the drug would not have been available.'

FDA officials said the new reports did not change the agencys position on the risks and benefits of the controversial drug, which received a black box warning that included suicide the strongest caution possible in 2009.

Agency officials said they are continuing to review Chantix in clinical trials.

But Mr said the new data should raise immediate alarms about the drug that was prescribed 3.2 million times last year to people trying to stop smoking and 1.1 million times already this year.

He said: 'To us, it raises questions about whether this drug is safe for widespread clinical use.'

Pfizer officials said that the firm was following the FDA's rules and changed their reporting process once the agency asked for clarification.

Standing by its product: Despite the controversy, Pfizer continues to say there's no proof that taking Chantix can lead to suicide

The company said: 'All post-marketing reports of adverse events are reviewed by Pfizer and reported to regulators, including FDA, in accordance with regulatory guidelines.

'Pfizer takes patient safety and regulatory reporting obligations very seriously.'

The FDA requires drugmakers to submit adverse events in two ways.Theres an 'expedited' system that requires companies to report serious and unexpected adverse events into the AERS system within 15 days.

Then there's the less-serious and expected adverse events to be submitted quarterly in so-called 'periodic reports.'

In those cases, problems previously included on drug labels including suicide and suicide attempts are considered to be expected events.

In Pfizers case, the firm was submitting the periodic reports as required, but combining summaries and individual case reports in a single text file, the FDA said.

That meant that the individual reports of injury were not logged in the FDAs AERS system, drastically reducing known reports of suicides and other psychiatric problems tied to Chantix, Mr said.

He said: 'Its very clear the suicide risk of this drug was higher than we knew.'

Overall, there were 1,055 reports of serious problems with Chantix reported in the third quarter of 2010, more than any other prescription medication regularly monitored by the drug safety agency, Mr added.

Before last July, the FDA had logged 122 reports of suicides linked to Chantix, including 37 reported by Pfizer and 85 reported by health professionals or consumers.

After the 150 new Pfizer reports were added, the total jumped to 272.

In addition, the 589 new reports of severe problems included 102 cases of possible hostility and aggression, 156 cases of depression and 56 cases of possible psychosis.

Those were mixed among the 26,000 reports of less-serious problems.

Mr has asked the FDA to investigate the 150 new suicide reports, particularly if the events occurred before the 2009 black box warning listed suicide as a possible side effect.

FDA officials said they are considering changing regulations to allow expedited reports of suicides and other serious problems, even if theyve previously been identified as expected. Read more: http://www.dailymail.co.uk/health/article-1391774/Suicide-horror-smoking-drug-Chantix-fatality-reports-left-safety-review.html#ixzz1NjBXwvdQ

[Guest guest]

High suicide rates related to anti-smoking drug Chantix were 'left out of crucial safety review'

By Daily Mail Reporter

Last updated at 4:43 AM on 28th May 2011

http://www.facebook.com/2008/fbml" />

Comments (6)

Add to My Stories

Share

Hundreds of reports of suicides and violent reactions tied to the stop-smoking drug Chantix were left out of a crucial government safety review.

The reports were missing because the drugs manufacturer Pfizer Inc. submitted years of data through 'improper channels', according to the Food and Drug Administration.

Serious problems such as people killing themselves, trying to kill themselves, depression and unprovoked attacks on others were mixed among 26,000 records of non-serious side effects such as nausea and rashes dating back to 2006, the year Chantix, or varenicline, was approved.

Controversial chemicals: Chantix is regarded as one of the 'riskiest' drugs by some scientists

Cases of 150 suicides, more than doubling those previously known, were among 589 delayed reports of severe issues uncovered in new analysis by the Institute for Safe Medication Practices (ISMP).

J , the senior scientist who analysed the data for the non-profit ISMP, said: 'Its really chilling. This seems to unleash something in people. It can be violence to anything around. Weve had a major breakdown in safety surveillance.'

His analysis echoes previous horror stories that Chantix can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and violent outbursts.

Federal Food and Drug Administration officials said that they asked Pfizer to resubmit thousands of records after realising that the company was sending required reports in an inappropriate format that could not be added to the agencys Adverse Events Reporting System, or AERS.

The agency said: 'Last year, the FDA became aware that a few manufacturers were submitting adverse events reports to FDA through improper channels.'

Extreme reactions: Approved in 2006, Chantix has been dogged by stories of unprovoked violencePfizer officials said they were submitting reports as required and that when the FDA asked them to change, they did so immediately. But they added that there's no proof that Chantix causes suicide or other serious side effects.

Mr , who has served as an expert witness in court cases related to Chantix, said it is the riskiest drug among those analysed from the FDA's adverse event reports, msnbc.com reports.

In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said.

, who has served as an expert witness in court regarding Chantix, said it's the riskiest drug among those analysed from the FDA's adverse event reports.

In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said.

WOMAN HIT SLEEPING LOVER FOR NO REASON

Scientist , who has studied Chantix, reported cases that describe 'inexplicable' reactions in patients, including:

A 24-year-old woman who started beating her boyfriend in bed because 'he looked so peaceful' and later attempted suicide.

A 42-year-old man who punched a stranger at a bowling alley.

A 47-year-old woman who died after she came out of a room, yelled at her daughters and then shot herself.

MURDER-SUICIDE OF CHANTIX RAGE HUSBAND

M Wain, 34, of Beaver County, Pennsylvania, shot himself and his wife, , 33, in May 2009 in what a lawyer for their families claims was a Chantix-fuelled rage.

Victor H. Prebanic, who represents the fathers of the slain couple, said: 'If the FDA had more information about suicides and other side effects tied to Chantix, the agency might have taken stronger action sooner. If Pfizer had been more forthcoming, the black box warning might have emerged earlier.

'For all we know, the drug would not have been available.'

FDA officials said the new reports did not change the agencys position on the risks and benefits of the controversial drug, which received a black box warning that included suicide the strongest caution possible in 2009.

Agency officials said they are continuing to review Chantix in clinical trials.

But Mr said the new data should raise immediate alarms about the drug that was prescribed 3.2 million times last year to people trying to stop smoking and 1.1 million times already this year.

He said: 'To us, it raises questions about whether this drug is safe for widespread clinical use.'

Pfizer officials said that the firm was following the FDA's rules and changed their reporting process once the agency asked for clarification.

Standing by its product: Despite the controversy, Pfizer continues to say there's no proof that taking Chantix can lead to suicide

The company said: 'All post-marketing reports of adverse events are reviewed by Pfizer and reported to regulators, including FDA, in accordance with regulatory guidelines.

'Pfizer takes patient safety and regulatory reporting obligations very seriously.'

The FDA requires drugmakers to submit adverse events in two ways.Theres an 'expedited' system that requires companies to report serious and unexpected adverse events into the AERS system within 15 days.

Then there's the less-serious and expected adverse events to be submitted quarterly in so-called 'periodic reports.'

In those cases, problems previously included on drug labels including suicide and suicide attempts are considered to be expected events.

In Pfizers case, the firm was submitting the periodic reports as required, but combining summaries and individual case reports in a single text file, the FDA said.

That meant that the individual reports of injury were not logged in the FDAs AERS system, drastically reducing known reports of suicides and other psychiatric problems tied to Chantix, Mr said.

He said: 'Its very clear the suicide risk of this drug was higher than we knew.'

Overall, there were 1,055 reports of serious problems with Chantix reported in the third quarter of 2010, more than any other prescription medication regularly monitored by the drug safety agency, Mr added.

Before last July, the FDA had logged 122 reports of suicides linked to Chantix, including 37 reported by Pfizer and 85 reported by health professionals or consumers.

After the 150 new Pfizer reports were added, the total jumped to 272.

In addition, the 589 new reports of severe problems included 102 cases of possible hostility and aggression, 156 cases of depression and 56 cases of possible psychosis.

Those were mixed among the 26,000 reports of less-serious problems.

Mr has asked the FDA to investigate the 150 new suicide reports, particularly if the events occurred before the 2009 black box warning listed suicide as a possible side effect.

FDA officials said they are considering changing regulations to allow expedited reports of suicides and other serious problems, even if theyve previously been identified as expected. Read more: http://www.dailymail.co.uk/health/article-1391774/Suicide-horror-smoking-drug-Chantix-fatality-reports-left-safety-review.html#ixzz1NjBXwvdQ

[Guest guest]

High suicide rates related to anti-smoking drug Chantix were 'left out of crucial safety review'

By Daily Mail Reporter

Last updated at 4:43 AM on 28th May 2011

http://www.facebook.com/2008/fbml" />

Comments (6)

Add to My Stories

Share

Hundreds of reports of suicides and violent reactions tied to the stop-smoking drug Chantix were left out of a crucial government safety review.

The reports were missing because the drugs manufacturer Pfizer Inc. submitted years of data through 'improper channels', according to the Food and Drug Administration.

Serious problems such as people killing themselves, trying to kill themselves, depression and unprovoked attacks on others were mixed among 26,000 records of non-serious side effects such as nausea and rashes dating back to 2006, the year Chantix, or varenicline, was approved.

Controversial chemicals: Chantix is regarded as one of the 'riskiest' drugs by some scientists

Cases of 150 suicides, more than doubling those previously known, were among 589 delayed reports of severe issues uncovered in new analysis by the Institute for Safe Medication Practices (ISMP).

J , the senior scientist who analysed the data for the non-profit ISMP, said: 'Its really chilling. This seems to unleash something in people. It can be violence to anything around. Weve had a major breakdown in safety surveillance.'

His analysis echoes previous horror stories that Chantix can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and violent outbursts.

Federal Food and Drug Administration officials said that they asked Pfizer to resubmit thousands of records after realising that the company was sending required reports in an inappropriate format that could not be added to the agencys Adverse Events Reporting System, or AERS.

The agency said: 'Last year, the FDA became aware that a few manufacturers were submitting adverse events reports to FDA through improper channels.'

Extreme reactions: Approved in 2006, Chantix has been dogged by stories of unprovoked violencePfizer officials said they were submitting reports as required and that when the FDA asked them to change, they did so immediately. But they added that there's no proof that Chantix causes suicide or other serious side effects.

Mr , who has served as an expert witness in court cases related to Chantix, said it is the riskiest drug among those analysed from the FDA's adverse event reports, msnbc.com reports.

In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said.

, who has served as an expert witness in court regarding Chantix, said it's the riskiest drug among those analysed from the FDA's adverse event reports.

In the third quarter of 2010, it ranked first in reported deaths, with twice as many fatalities logged as any other drug, he said.

WOMAN HIT SLEEPING LOVER FOR NO REASON

Scientist , who has studied Chantix, reported cases that describe 'inexplicable' reactions in patients, including:

A 24-year-old woman who started beating her boyfriend in bed because 'he looked so peaceful' and later attempted suicide.

A 42-year-old man who punched a stranger at a bowling alley.

A 47-year-old woman who died after she came out of a room, yelled at her daughters and then shot herself.

MURDER-SUICIDE OF CHANTIX RAGE HUSBAND

M Wain, 34, of Beaver County, Pennsylvania, shot himself and his wife, , 33, in May 2009 in what a lawyer for their families claims was a Chantix-fuelled rage.

Victor H. Prebanic, who represents the fathers of the slain couple, said: 'If the FDA had more information about suicides and other side effects tied to Chantix, the agency might have taken stronger action sooner. If Pfizer had been more forthcoming, the black box warning might have emerged earlier.

'For all we know, the drug would not have been available.'

FDA officials said the new reports did not change the agencys position on the risks and benefits of the controversial drug, which received a black box warning that included suicide the strongest caution possible in 2009.

Agency officials said they are continuing to review Chantix in clinical trials.

But Mr said the new data should raise immediate alarms about the drug that was prescribed 3.2 million times last year to people trying to stop smoking and 1.1 million times already this year.

He said: 'To us, it raises questions about whether this drug is safe for widespread clinical use.'

Pfizer officials said that the firm was following the FDA's rules and changed their reporting process once the agency asked for clarification.

Standing by its product: Despite the controversy, Pfizer continues to say there's no proof that taking Chantix can lead to suicide

The company said: 'All post-marketing reports of adverse events are reviewed by Pfizer and reported to regulators, including FDA, in accordance with regulatory guidelines.

'Pfizer takes patient safety and regulatory reporting obligations very seriously.'

The FDA requires drugmakers to submit adverse events in two ways.Theres an 'expedited' system that requires companies to report serious and unexpected adverse events into the AERS system within 15 days.

Then there's the less-serious and expected adverse events to be submitted quarterly in so-called 'periodic reports.'

In those cases, problems previously included on drug labels including suicide and suicide attempts are considered to be expected events.

In Pfizers case, the firm was submitting the periodic reports as required, but combining summaries and individual case reports in a single text file, the FDA said.

That meant that the individual reports of injury were not logged in the FDAs AERS system, drastically reducing known reports of suicides and other psychiatric problems tied to Chantix, Mr said.

He said: 'Its very clear the suicide risk of this drug was higher than we knew.'

Overall, there were 1,055 reports of serious problems with Chantix reported in the third quarter of 2010, more than any other prescription medication regularly monitored by the drug safety agency, Mr added.

Before last July, the FDA had logged 122 reports of suicides linked to Chantix, including 37 reported by Pfizer and 85 reported by health professionals or consumers.

After the 150 new Pfizer reports were added, the total jumped to 272.

In addition, the 589 new reports of severe problems included 102 cases of possible hostility and aggression, 156 cases of depression and 56 cases of possible psychosis.

Those were mixed among the 26,000 reports of less-serious problems.

Mr has asked the FDA to investigate the 150 new suicide reports, particularly if the events occurred before the 2009 black box warning listed suicide as a possible side effect.

FDA officials said they are considering changing regulations to allow expedited reports of suicides and other serious problems, even if theyve previously been identified as expected. Read more: http://www.dailymail.co.uk/health/article-1391774/Suicide-horror-smoking-drug-Chantix-fatality-reports-left-safety-review.html#ixzz1NjBXwvdQ