Smoking-pill suicides overlooked in missing reports

[Guest guest]

http://www.msnbc.msn.com/id/43187290/ns/health-health_care#

Smoking-pill suicides

overlooked in missing reports

Drugmaker sent data through

'improper channels;' FDA didn't have full picture of safety

By JoNel Aleccia Health writer

msnbc.com

updated 5/27/2011

8:34:38 AM ET

Hundreds of reports of suicides, psychotic

reactions and other serious problems tied to the popular

stop-smoking drug Chantix were left out of a crucial

government safety review because Pfizer Inc., the drug’s

manufacturer, submitted years of data through “improper

channels.”

Some 150 suicides — more than doubling those previously known

— were among 589 delayed reports of severe issues turned up in

a new analysis by the non-profit Institute for Safe Medication

Practices.

“We’ve had a major breakdown in safety surveillance,” said

J. , the ISMP senior scientist who analyzed

the data. The serious problems — including reports of

completed suicides, suicide attempts, aggression and hostility

and depression — had been mixed among some 26,000 records of

non-serious side effects such as nausea and rashes, with some

dating back to 2006, the year Chantix, or varenicline, was

approved.

They echo previous claims that the drug can induce extreme

reactions in people trying to quit cigarettes, including vivid

nightmares, crippling depression and sudden, violent

outbursts.

“It’s really chilling,” said , who analyzed 26 Chantix

reactions in a paper published in the September 2010 issue of

the Journal of Pharmacotherapy. "This seems to unleash

something in people. It can be violence to anything around."

's case studies describe "inexplicable and unprovoked"

reactions in Chantix patients with no previous history of

violence or mental illness, 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.

Federal Food and Drug Administration officials acknowledged

that they asked Pfizer to resubmit thousands of records after

realizing that the company was sending required reports in an

inappropriate format that could not be added to the agency’s

Adverse Events Reporting System, or AERS.

“Last year, FDA became aware that a few manufacturers were

submitting adverse events reports to FDA through improper

channels,” the agency said in a statement.

Pfizer officials said they were submitting reports as

required and that when the FDA asked them to change, they did

so immediately. They said there's no proof that Chantix causes

suicide or other serious side effects.

, who has served as an expert witness in court regarding

Chantix, said it's the riskiest drug among those analyzed 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.

New reports don't change FDA's position

FDA officials said the new reports did not change the

agency’s 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,

according to agency officials who would not speak on the

record.

“At this point, based on the data, FDA does not have any new

safety concerns with Chantix, though those that have been

established remain under active review,” the agency said in a

statement posted in response to the ISMP report.

Agency officials said they're continuing to review Chantix in

clinical trials and two large observational studies with the

Veterans Administration and the Department of Defense.

But 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, according to data from the firm Wolters

Kluwer Pharma Solutions.

“To us, it raises questions about whether this drug is safe

for widespread clinical use,” said. “Does this tip the

balance?”

That’s a view echoed by families of people who allegedly

became suddenly and inexplicably violent after taking Chantix.

M. Wain, 34, of Beaver County, Pa., shot himself and his

wife, , 33, in May 2009 in what a lawyer for their

families claims was a Chantix-fueled rage.

If the FDA had more information about suicides and other side

effects tied to Chantix, the agency might have taken stronger

action sooner, said Victor H. Prebanic, who represents

Erdelen and Wain, fathers of the slain couple.

“If Pfizer had been more forthcoming, the black box warning

might have emerged earlier,” Prebanic said. “For all we know,

the drug would not have been available.”

The lawsuit, filed this month, is the latest among hundreds

of claims filed against Pfizer regarding Chantix. At least

1,545 injury claims that cite Chantix are pending in federal

court.

Pfizer officials, however, said that the firm was following

the FDA's rules and changed their reporting process once the

agency asked for clarification.

“All post-marketing reports of adverse events are reviewed by

Pfizer and reported to regulators, including FDA, in

accordance with regulatory guidelines,” the company said in a

statement. “Pfizer takes patient safety and regulatory

reporting obligations very seriously.”

Suicide is an 'expected' event?

The problem appears to have been caused in part by

federal Food and Drug Administration rules that don’t require

firms to submit new reports of death or serious harm in the

agency’s system for urgent review when such risks are already

known.

FDA requires drugmakers to submit adverse events in two ways:

There’s an “expedited” system that requires companies to

report serious and unexpected adverse events into the AERS

system within 15 days.

Companies are also required to submit less-serious and

expected adverse events 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 Pfizer’s 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 FDA’s AERS system, drastically reducing known

reports of suicides and other psychiatric problems tied to

Chantix, said.

“It’s very clear the suicide risk of this drug was higher than

we knew,” he said.

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, said.

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, reported.

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.

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.

For their part, FDA officials said they are considering

changing regulations to allow expedited reports of suicides and

other serious problems, even if they’ve previously been

identified as expected. First proposed in 2003, that change is

still pending.

Follow health reporter JoNel Aleccia on Twitter @jonel_aleccia

© 2011 msnbc.com

Reprints

[Guest guest]

http://www.msnbc.msn.com/id/43187290/ns/health-health_care#

Smoking-pill suicides

overlooked in missing reports

Drugmaker sent data through

'improper channels;' FDA didn't have full picture of safety

By JoNel Aleccia Health writer

msnbc.com

updated 5/27/2011

8:34:38 AM ET

Hundreds of reports of suicides, psychotic

reactions and other serious problems tied to the popular

stop-smoking drug Chantix were left out of a crucial

government safety review because Pfizer Inc., the drug’s

manufacturer, submitted years of data through “improper

channels.”

Some 150 suicides — more than doubling those previously known

— were among 589 delayed reports of severe issues turned up in

a new analysis by the non-profit Institute for Safe Medication

Practices.

“We’ve had a major breakdown in safety surveillance,” said

J. , the ISMP senior scientist who analyzed

the data. The serious problems — including reports of

completed suicides, suicide attempts, aggression and hostility

and depression — had been mixed among some 26,000 records of

non-serious side effects such as nausea and rashes, with some

dating back to 2006, the year Chantix, or varenicline, was

approved.

They echo previous claims that the drug can induce extreme

reactions in people trying to quit cigarettes, including vivid

nightmares, crippling depression and sudden, violent

outbursts.

“It’s really chilling,” said , who analyzed 26 Chantix

reactions in a paper published in the September 2010 issue of

the Journal of Pharmacotherapy. "This seems to unleash

something in people. It can be violence to anything around."

's case studies describe "inexplicable and unprovoked"

reactions in Chantix patients with no previous history of

violence or mental illness, 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.

Federal Food and Drug Administration officials acknowledged

that they asked Pfizer to resubmit thousands of records after

realizing that the company was sending required reports in an

inappropriate format that could not be added to the agency’s

Adverse Events Reporting System, or AERS.

“Last year, FDA became aware that a few manufacturers were

submitting adverse events reports to FDA through improper

channels,” the agency said in a statement.

Pfizer officials said they were submitting reports as

required and that when the FDA asked them to change, they did

so immediately. They said there's no proof that Chantix causes

suicide or other serious side effects.

, who has served as an expert witness in court regarding

Chantix, said it's the riskiest drug among those analyzed 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.

New reports don't change FDA's position

FDA officials said the new reports did not change the

agency’s 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,

according to agency officials who would not speak on the

record.

“At this point, based on the data, FDA does not have any new

safety concerns with Chantix, though those that have been

established remain under active review,” the agency said in a

statement posted in response to the ISMP report.

Agency officials said they're continuing to review Chantix in

clinical trials and two large observational studies with the

Veterans Administration and the Department of Defense.

But 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, according to data from the firm Wolters

Kluwer Pharma Solutions.

“To us, it raises questions about whether this drug is safe

for widespread clinical use,” said. “Does this tip the

balance?”

That’s a view echoed by families of people who allegedly

became suddenly and inexplicably violent after taking Chantix.

M. Wain, 34, of Beaver County, Pa., shot himself and his

wife, , 33, in May 2009 in what a lawyer for their

families claims was a Chantix-fueled rage.

If the FDA had more information about suicides and other side

effects tied to Chantix, the agency might have taken stronger

action sooner, said Victor H. Prebanic, who represents

Erdelen and Wain, fathers of the slain couple.

“If Pfizer had been more forthcoming, the black box warning

might have emerged earlier,” Prebanic said. “For all we know,

the drug would not have been available.”

The lawsuit, filed this month, is the latest among hundreds

of claims filed against Pfizer regarding Chantix. At least

1,545 injury claims that cite Chantix are pending in federal

court.

Pfizer officials, however, said that the firm was following

the FDA's rules and changed their reporting process once the

agency asked for clarification.

“All post-marketing reports of adverse events are reviewed by

Pfizer and reported to regulators, including FDA, in

accordance with regulatory guidelines,” the company said in a

statement. “Pfizer takes patient safety and regulatory

reporting obligations very seriously.”

Suicide is an 'expected' event?

The problem appears to have been caused in part by

federal Food and Drug Administration rules that don’t require

firms to submit new reports of death or serious harm in the

agency’s system for urgent review when such risks are already

known.

FDA requires drugmakers to submit adverse events in two ways:

There’s an “expedited” system that requires companies to

report serious and unexpected adverse events into the AERS

system within 15 days.

Companies are also required to submit less-serious and

expected adverse events 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 Pfizer’s 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 FDA’s AERS system, drastically reducing known

reports of suicides and other psychiatric problems tied to

Chantix, said.

“It’s very clear the suicide risk of this drug was higher than

we knew,” he said.

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, said.

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, reported.

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.

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.

For their part, FDA officials said they are considering

changing regulations to allow expedited reports of suicides and

other serious problems, even if they’ve previously been

identified as expected. First proposed in 2003, that change is

still pending.

Follow health reporter JoNel Aleccia on Twitter @jonel_aleccia

© 2011 msnbc.com

Reprints

[Guest guest]

http://www.msnbc.msn.com/id/43187290/ns/health-health_care#

Smoking-pill suicides

overlooked in missing reports

Drugmaker sent data through

'improper channels;' FDA didn't have full picture of safety

By JoNel Aleccia Health writer

msnbc.com

updated 5/27/2011

8:34:38 AM ET

Hundreds of reports of suicides, psychotic

reactions and other serious problems tied to the popular

stop-smoking drug Chantix were left out of a crucial

government safety review because Pfizer Inc., the drug’s

manufacturer, submitted years of data through “improper

channels.”

Some 150 suicides — more than doubling those previously known

— were among 589 delayed reports of severe issues turned up in

a new analysis by the non-profit Institute for Safe Medication

Practices.

“We’ve had a major breakdown in safety surveillance,” said

J. , the ISMP senior scientist who analyzed

the data. The serious problems — including reports of

completed suicides, suicide attempts, aggression and hostility

and depression — had been mixed among some 26,000 records of

non-serious side effects such as nausea and rashes, with some

dating back to 2006, the year Chantix, or varenicline, was

approved.

They echo previous claims that the drug can induce extreme

reactions in people trying to quit cigarettes, including vivid

nightmares, crippling depression and sudden, violent

outbursts.

“It’s really chilling,” said , who analyzed 26 Chantix

reactions in a paper published in the September 2010 issue of

the Journal of Pharmacotherapy. "This seems to unleash

something in people. It can be violence to anything around."

's case studies describe "inexplicable and unprovoked"

reactions in Chantix patients with no previous history of

violence or mental illness, 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.

Federal Food and Drug Administration officials acknowledged

that they asked Pfizer to resubmit thousands of records after

realizing that the company was sending required reports in an

inappropriate format that could not be added to the agency’s

Adverse Events Reporting System, or AERS.

“Last year, FDA became aware that a few manufacturers were

submitting adverse events reports to FDA through improper

channels,” the agency said in a statement.

Pfizer officials said they were submitting reports as

required and that when the FDA asked them to change, they did

so immediately. They said there's no proof that Chantix causes

suicide or other serious side effects.

, who has served as an expert witness in court regarding

Chantix, said it's the riskiest drug among those analyzed 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.

New reports don't change FDA's position

FDA officials said the new reports did not change the

agency’s 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,

according to agency officials who would not speak on the

record.

“At this point, based on the data, FDA does not have any new

safety concerns with Chantix, though those that have been

established remain under active review,” the agency said in a

statement posted in response to the ISMP report.

Agency officials said they're continuing to review Chantix in

clinical trials and two large observational studies with the

Veterans Administration and the Department of Defense.

But 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, according to data from the firm Wolters

Kluwer Pharma Solutions.

“To us, it raises questions about whether this drug is safe

for widespread clinical use,” said. “Does this tip the

balance?”

That’s a view echoed by families of people who allegedly

became suddenly and inexplicably violent after taking Chantix.

M. Wain, 34, of Beaver County, Pa., shot himself and his

wife, , 33, in May 2009 in what a lawyer for their

families claims was a Chantix-fueled rage.

If the FDA had more information about suicides and other side

effects tied to Chantix, the agency might have taken stronger

action sooner, said Victor H. Prebanic, who represents

Erdelen and Wain, fathers of the slain couple.

“If Pfizer had been more forthcoming, the black box warning

might have emerged earlier,” Prebanic said. “For all we know,

the drug would not have been available.”

The lawsuit, filed this month, is the latest among hundreds

of claims filed against Pfizer regarding Chantix. At least

1,545 injury claims that cite Chantix are pending in federal

court.

Pfizer officials, however, said that the firm was following

the FDA's rules and changed their reporting process once the

agency asked for clarification.

“All post-marketing reports of adverse events are reviewed by

Pfizer and reported to regulators, including FDA, in

accordance with regulatory guidelines,” the company said in a

statement. “Pfizer takes patient safety and regulatory

reporting obligations very seriously.”

Suicide is an 'expected' event?

The problem appears to have been caused in part by

federal Food and Drug Administration rules that don’t require

firms to submit new reports of death or serious harm in the

agency’s system for urgent review when such risks are already

known.

FDA requires drugmakers to submit adverse events in two ways:

There’s an “expedited” system that requires companies to

report serious and unexpected adverse events into the AERS

system within 15 days.

Companies are also required to submit less-serious and

expected adverse events 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 Pfizer’s 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 FDA’s AERS system, drastically reducing known

reports of suicides and other psychiatric problems tied to

Chantix, said.

“It’s very clear the suicide risk of this drug was higher than

we knew,” he said.

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, said.

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, reported.

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.

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.

For their part, FDA officials said they are considering

changing regulations to allow expedited reports of suicides and

other serious problems, even if they’ve previously been

identified as expected. First proposed in 2003, that change is

still pending.

Follow health reporter JoNel Aleccia on Twitter @jonel_aleccia

© 2011 msnbc.com

Reprints

[Guest guest]

http://www.msnbc.msn.com/id/43187290/ns/health-health_care#

Smoking-pill suicides

overlooked in missing reports

Drugmaker sent data through

'improper channels;' FDA didn't have full picture of safety

By JoNel Aleccia Health writer

msnbc.com

updated 5/27/2011

8:34:38 AM ET

Hundreds of reports of suicides, psychotic

reactions and other serious problems tied to the popular

stop-smoking drug Chantix were left out of a crucial

government safety review because Pfizer Inc., the drug’s

manufacturer, submitted years of data through “improper

channels.”

Some 150 suicides — more than doubling those previously known

— were among 589 delayed reports of severe issues turned up in

a new analysis by the non-profit Institute for Safe Medication

Practices.

“We’ve had a major breakdown in safety surveillance,” said

J. , the ISMP senior scientist who analyzed

the data. The serious problems — including reports of

completed suicides, suicide attempts, aggression and hostility

and depression — had been mixed among some 26,000 records of

non-serious side effects such as nausea and rashes, with some

dating back to 2006, the year Chantix, or varenicline, was

approved.

They echo previous claims that the drug can induce extreme

reactions in people trying to quit cigarettes, including vivid

nightmares, crippling depression and sudden, violent

outbursts.

“It’s really chilling,” said , who analyzed 26 Chantix

reactions in a paper published in the September 2010 issue of

the Journal of Pharmacotherapy. "This seems to unleash

something in people. It can be violence to anything around."

's case studies describe "inexplicable and unprovoked"

reactions in Chantix patients with no previous history of

violence or mental illness, 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.

Federal Food and Drug Administration officials acknowledged

that they asked Pfizer to resubmit thousands of records after

realizing that the company was sending required reports in an

inappropriate format that could not be added to the agency’s

Adverse Events Reporting System, or AERS.

“Last year, FDA became aware that a few manufacturers were

submitting adverse events reports to FDA through improper

channels,” the agency said in a statement.

Pfizer officials said they were submitting reports as

required and that when the FDA asked them to change, they did

so immediately. They said there's no proof that Chantix causes

suicide or other serious side effects.

, who has served as an expert witness in court regarding

Chantix, said it's the riskiest drug among those analyzed 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.

New reports don't change FDA's position

FDA officials said the new reports did not change the

agency’s 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,

according to agency officials who would not speak on the

record.

“At this point, based on the data, FDA does not have any new

safety concerns with Chantix, though those that have been

established remain under active review,” the agency said in a

statement posted in response to the ISMP report.

Agency officials said they're continuing to review Chantix in

clinical trials and two large observational studies with the

Veterans Administration and the Department of Defense.

But 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, according to data from the firm Wolters

Kluwer Pharma Solutions.

“To us, it raises questions about whether this drug is safe

for widespread clinical use,” said. “Does this tip the

balance?”

That’s a view echoed by families of people who allegedly

became suddenly and inexplicably violent after taking Chantix.

M. Wain, 34, of Beaver County, Pa., shot himself and his

wife, , 33, in May 2009 in what a lawyer for their

families claims was a Chantix-fueled rage.

If the FDA had more information about suicides and other side

effects tied to Chantix, the agency might have taken stronger

action sooner, said Victor H. Prebanic, who represents

Erdelen and Wain, fathers of the slain couple.

“If Pfizer had been more forthcoming, the black box warning

might have emerged earlier,” Prebanic said. “For all we know,

the drug would not have been available.”

The lawsuit, filed this month, is the latest among hundreds

of claims filed against Pfizer regarding Chantix. At least

1,545 injury claims that cite Chantix are pending in federal

court.

Pfizer officials, however, said that the firm was following

the FDA's rules and changed their reporting process once the

agency asked for clarification.

“All post-marketing reports of adverse events are reviewed by

Pfizer and reported to regulators, including FDA, in

accordance with regulatory guidelines,” the company said in a

statement. “Pfizer takes patient safety and regulatory

reporting obligations very seriously.”

Suicide is an 'expected' event?

The problem appears to have been caused in part by

federal Food and Drug Administration rules that don’t require

firms to submit new reports of death or serious harm in the

agency’s system for urgent review when such risks are already

known.

FDA requires drugmakers to submit adverse events in two ways:

There’s an “expedited” system that requires companies to

report serious and unexpected adverse events into the AERS

system within 15 days.

Companies are also required to submit less-serious and

expected adverse events 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 Pfizer’s 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 FDA’s AERS system, drastically reducing known

reports of suicides and other psychiatric problems tied to

Chantix, said.

“It’s very clear the suicide risk of this drug was higher than

we knew,” he said.

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, said.

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, reported.

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.

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.

For their part, FDA officials said they are considering

changing regulations to allow expedited reports of suicides and

other serious problems, even if they’ve previously been

identified as expected. First proposed in 2003, that change is

still pending.

Follow health reporter JoNel Aleccia on Twitter @jonel_aleccia

© 2011 msnbc.com

Reprints