Pfizer - were asked to a add suicide warning on Lustral/Zoloft Aug 2000

Pfizer - were asked to a add suicide warning on Lustral/Zoloft Aug 2000

Joined: April 1st, 2004, 4:56 pm

April 9th, 2009, 9:01 pm #1

<table cellspacing="0" cellpadding="0"><tr><td><strong>http://health.groups.yahoo.com/group/SS ... sage/33916</strong><strong></strong> <strong></strong> <strong></strong> <strong>The following information was supplied to Jeremy Bryce as a result of Freedom of Information request number - FOI 09 086 </strong>
<strong>Mr Bryce asked which makers of antidepressants received a request (year 2000) to include the following statement in product information: </strong><font size="3"></font>

<strong>[font=]"Occasionally thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with (insert name of drug) , until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences." [/font]</strong>

<strong>[font=][/font]</strong> 

<strong>[text redacted S40 FOIA] </strong>

<strong>Manager, Regulatory Affairs </strong>

<strong>Pfizer Limited </strong>

<strong>14 August 2000 </strong>

<strong>Dear[text redacted S40 FOIA] </strong>
<font size="3" face="Times New Roman,Times New Roman"></font>
<strong>RE: SSRIs and suicidal behaviour </strong>

<strong>As you are aware, the Committee on Safety of Medicines (CSM) has recently reviewed the issue of fluoxetine and other SSRIs and suicidal behaviour. The Committee concluded that the available study data did not support a causal association between SSRIs and suicidal behaviour. However there continued to be anecdotal reports of suicidal behaviour associated with SSRIs. The Committee noted that it was general clinical experience that patients taking antidepressants may develop an increase in suicidal behaviour in the first few weeks of treatment. </strong>

<strong>The CSM considered that patient information leaflets for SSRIs should be updated to ensure consistency with the SPC statement introduced in the recent SSRI core safety exercise. They felt that the following wording was appropriate: </strong>

<strong>'Occasionally, thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with sertraline, until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences.' </strong>

<strong>Your variation to update the SPC is about to be submitted. I would be grateful if you would revise PIL to include the above statement. </strong>

<strong>Please do not hesitate to contact me if you require any further information. </strong>

<strong>Yours sincerely </strong>

<strong>[text redacted S38 FOIA] </strong>

<strong>Senior Scientific Assessor </strong>

<strong>Pharmacovigilance Group </strong>

<strong>Copy: [text redacted S38 FOIA]</strong>


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Joined: April 1st, 2004, 4:56 pm

April 9th, 2009, 9:02 pm #2

<strong>http://health.groups.yahoo.com/group/SS ... sage/33917</strong><strong></strong> <strong></strong> <strong></strong> <strong>The following information was supplied to Jeremy Bryce as a result of Freedom of Information request number - FOI 09 086 </strong>
<strong>Mr Bryce asked which makers of antidepressants received a request (year 2000) to include the following statement in product information: </strong><font size="3"></font>

<strong>[font=]"Occasionally thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with (insert name of drug) , until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences." [/font]</strong>

<strong><em>[font=][/font]</em></strong> 

<strong><em>[font=][/font]</em></strong> 

text redacted S40 FOIA]

Solvay Healthcare Limited

14 August 2000

Dear [text redacted S40 FOIA]
<font size="3" face="Times New Roman,Times New Roman"></font>
RE: SSRIs and suicidal behaviour

I am writing further to our telephone discussion today. As you are aware, the Committee on Safety of Medicines (CSM) has recently reviewed the issue of fluoxetine and other SSRIs and suicidal behaviour. The Committee concluded that the available study data did not support a causal association between SSRIs and suicidal behaviour. However there continued to be anecdotal reports of suicidal behaviour associated with SSRIs. The Committee noted that it was general clinical experience that patients taking antidepressants may develop an increase in suicidal behaviour in the first few weeks of treatment.

The CSM considered that patient information leaflets for SSRIs should be updated to ensure consistency with the SPC statement introduced in the recent SSRI core safety exercise. They felt that the following wording was appropriate:

'Occasionally, thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with fluvoxamine, until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences.'

Your variation to update the Faverin SPC is currently under assessment. I would be grateful if you would submit a revised PIL including the above statement.

Please do not hesitate to contact me if you have any queries regarding this.

Yours sincerely

[text redacted S38 FOIA]

Senior Scientific Assessor

Pharmacovigilance Group

Copy: [text redacted S38 FOIA]

http://health.groups.yahoo.com/group/cr ... ssage/9864





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Joined: April 1st, 2004, 4:56 pm

April 9th, 2009, 9:03 pm #3


<strong>http://health.groups.yahoo.com/group/SS ... sage/33918</strong>

<strong></strong> 

<strong></strong> 

<strong>The following information was supplied to Jeremy Bryce as a result of Freedom of Information request number - FOI 09 086 </strong>

<strong>Mr Bryce asked which makers of antidepressants received a request (year 2000) to include the following statement in product information: </strong><font size="3"></font>

<strong>[font=]"Occasionally thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with (insert name of drug) , until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences." [/font]</strong>

<strong>[font=][/font]</strong> 

<strong>[font=][/font]</strong> 

text redacted S40 FOIA]

Lundbeck Limited

11 August 2000

Dear[text redacted S40 FOIA]
<font size="3" face="Times New Roman,Times New Roman"></font>
RE: SSRIs and suicidal behaviour

As you are aware, the Committee on Safety of Medicines (CSM) has recently reviewed the issue of fluoxetine and other SSRIs and suicidal behaviour. The Committee concluded that the available study data did not support a causal association between SSRIs and suicidal behaviour. However there continued to be anecdotal reports of suicidal behaviour associated with SSRIs. The Committee noted that it was general clinical experience that patients taking antidepressants may develop an increase in suicidal behaviour in the first few weeks of treatment.

The CSM considered that patient information leaflets for SSRIs should be updated to ensure consistency with the SPC statement introduced in the recent SSRI core safety exercise. They felt that the following wording was appropriate:

'Occasionally, thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with citalopram, until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences.'

Your variation to update the SPC is currently under assessment. I would be grateful if you would submit a revised PIL including the above statement. I have assessed the PIL as it stands and no other amendments are required.

Please do not hesitate to contact me if you require any further information.

Yours sincerely

[text redacted S38 FOIA]

Senior Scientific Assessor

Pharmacovigilance Group

Copy: [text redacted S38 FOIA]

<em><strong></strong></em> 

<em><strong></strong></em> 

<strong>http://health.groups.yahoo.com/group/cr ... ssage/9864</strong>



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Joined: April 1st, 2004, 4:56 pm

April 9th, 2009, 9:04 pm #4


<strong></strong> 

<strong>http://health.groups.yahoo.com/group/SS ... sage/33919</strong>

<strong></strong> 

<strong>The following information was supplied to Jeremy Bryce as a result of Freedom of Information request number - FOI 09 086 </strong>

<strong>Mr Bryce asked which makers of antidepressants received a request (year 2000) to include the following statement in product information: </strong><font size="3"></font>

<strong>[font=]"Occasionally thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with (insert name of drug) , until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences." [/font]</strong>

<strong>[font=][/font]</strong> 

[font=][/font] 

[text redacted S40 FOIA]

Eli Lilly and Company Limited
<font size="3" face="Times New Roman,Times New Roman"></font>
By Fax: 01256 315435

16 August 2000

Dear [text redacted S40 FOIA]
<font size="3" face="Times New Roman,Times New Roman"></font>
RE: SSRIs and suicidal behaviour

Thank you for your e-mail with the proposed wording relating to suicide for the Prozac PIL.

The wording that you propose implies that thoughts of suicide that are already present may not get better immediately. This is not entirely consistent with the wording recently added to the Prozac SPC which states that the risk of suicide may increase in early stages of recovery.

'Suicide: As improvement may not occur during the first few weeks of treatment, in common with all antidepressants, patients should be closely monitored during this period. The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. <font size="3"><font face="">It is general clinical experience with all therapies for depression that the risk of suicide may increase in the early stages of recovery</font></font>.'

I therefore request that you incorporate the following wording which is proposed by the CSM into the statement that Lilly have developed:

'Occasionally, thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with fluoxetine, until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences.'

I will be away from the office from 18th to 1st August inclusive. In me absence, please contact [text redacted S38 FOIA]if you have any questions (telephone number [text redacted S38 FOIA]

Yours sincerely

[text redacted S38 FOIA]

Senior Scientific Assessor

Pharmacovigilance Group

Copy: [text redacted S38 FOIA]

 

http://health.groups.yahoo.com/group/cr ... ssage/9864

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Joined: April 1st, 2004, 4:56 pm

April 9th, 2009, 9:06 pm #5


<strong></strong> 

<strong>http://health.groups.yahoo.com/group/SS ... sage/33920</strong>

<strong></strong> 

<strong>The following information was supplied to Jeremy Bryce as a result of Freedom of Information request number - FOI 09 086 </strong>

<strong>Mr Bryce asked which makers of antidepressants received a request (year 2000) to include the following statement in product information: </strong><font size="3"></font>

<strong>[font=]"Occasionally thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with (insert name of drug) , until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences." [/font]</strong>

<strong>[font=][/font]</strong> 

[font=][/font] 

[text redacted S40 FOIA]

SmithKline Beecham Pharmaceuticals

11 August 2000

Dear[text redacted S40 FOIA]
<font size="3" face="Times New Roman,Times New Roman"></font>
RE: SSRIs and suicidal behaviour

As you are aware, the Committee on Safety of Medicines (CSM) has recently reviewed the issue of fluoxetine and other SSRIs and suicidal behaviour. The Committee concluded that the available study data did not support a causal association between SSRIs and suicidal behaviour. However there continued to be anecdotal reports of suicidal behaviour associated with SSRIs. The Committee noted that it was general clinical experience that patients taking antidepressants may develop an increase in suicidal behaviour in the first few weeks of treatment.

The CSM considered that patient information leaflets for SSRIs should be updated to ensure consistency with the SPC statement introduced in the recent SSRI core safety exercise. They felt that the following wording was appropriate:

'Occasionally, thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with paroxetine, until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences.'

Your variation to update the SPC is currently under assessment. I would be grateful if you would submit a revised PIL including the above statement. I have assessed the PIL as it stands and no other amendments are required.

Please do not hesitate to contact me if you require any further information.

Yours sincerely

[text redacted S38 FOIA]

Senior Scientific Assessor

Pharmacovigilance Group

Copy: [text redacted S38 FOIA]

 

http://health.groups.yahoo.com/group/cr ... ssage/9864

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Joined: April 1st, 2004, 4:56 pm

April 10th, 2009, 8:26 am #6

<table cellspacing="0" cellpadding="0"><tr><td><strong>http://health.groups.yahoo.com/group/SS ... sage/33916</strong><strong></strong> <strong></strong> <strong></strong> <strong>The following information was supplied to Jeremy Bryce as a result of Freedom of Information request number - FOI 09 086 </strong>
<strong>Mr Bryce asked which makers of antidepressants received a request (year 2000) to include the following statement in product information: </strong><font size="3"></font>

<strong>[font=]"Occasionally thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with (insert name of drug) , until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences." [/font]</strong>

<strong>[font=][/font]</strong> 

<strong>[text redacted S40 FOIA] </strong>

<strong>Manager, Regulatory Affairs </strong>

<strong>Pfizer Limited </strong>

<strong>14 August 2000 </strong>

<strong>Dear[text redacted S40 FOIA] </strong>
<font size="3" face="Times New Roman,Times New Roman"></font>
<strong>RE: SSRIs and suicidal behaviour </strong>

<strong>As you are aware, the Committee on Safety of Medicines (CSM) has recently reviewed the issue of fluoxetine and other SSRIs and suicidal behaviour. The Committee concluded that the available study data did not support a causal association between SSRIs and suicidal behaviour. However there continued to be anecdotal reports of suicidal behaviour associated with SSRIs. The Committee noted that it was general clinical experience that patients taking antidepressants may develop an increase in suicidal behaviour in the first few weeks of treatment. </strong>

<strong>The CSM considered that patient information leaflets for SSRIs should be updated to ensure consistency with the SPC statement introduced in the recent SSRI core safety exercise. They felt that the following wording was appropriate: </strong>

<strong>'Occasionally, thoughts of suicide or self harm may occur or may increase in the first few weeks of treatment with sertraline, until the antidepressant effect becomes apparent. Tell your doctor immediately if you have any distressing thoughts or experiences.' </strong>

<strong>Your variation to update the SPC is about to be submitted. I would be grateful if you would revise PIL to include the above statement. </strong>

<strong>Please do not hesitate to contact me if you require any further information. </strong>

<strong>Yours sincerely </strong>

<strong>[text redacted S38 FOIA] </strong>

<strong>Senior Scientific Assessor </strong>

<strong>Pharmacovigilance Group </strong>

<strong>Copy: [text redacted S38 FOIA]</strong>


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NOT JUST GSK

 

Seroxat is no more dangerous than any other SSRI & anyone who thinks otherwise is DELUDED
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Joined: April 1st, 2004, 4:56 pm

April 10th, 2009, 8:54 am #7

Lilly - GSK - all asked to put suicide warning on SSRI


NOT JUST GSK

<em><strong>Seroxat is no more dangerous than any other SSRI & anyone who thinks otherwise is DELUDED</strong></em>;
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Joined: April 1st, 2004, 4:56 pm

April 10th, 2009, 8:58 am #8

food for thought
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Joined: April 1st, 2004, 4:56 pm

April 10th, 2009, 9:18 am #9

NOT JUST GSK

 

Seroxat is no more dangerous than any other SSRI & anyone who thinks otherwise is DELUDED


 

Michael Mark Harvey -
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Joined: April 1st, 2004, 4:56 pm

April 10th, 2009, 9:28 am #10

NOT JUST GSK

 

Seroxat is no more dangerous than any other SSRI & anyone who thinks otherwise is DELUDED
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