MHRA press release ..........Seroxat/GSK

[Guest guest]

Press release

Date: 06 Mar 2008

Time: 09:30

Subject: GSK investigation concludes

Contact: Press Office 020 7084 3535/3564 or

press.office@...

Out-of-hours 07770 446 189

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON014152

The MHRA has concluded its four year investigation into

Glaxosmithkline and its antidepressant drug Seroxat. The

investigation focused on whether GSK had failed to inform the MHRA of

information it had on the safety of Seroxat in under 18's in a timely

manner. The investigation was undertaken with a view to a potential

criminal prosecution for breach of drug safety legislation. It was

the largest investigation of its kind in the UK, and included the

scrutiny of over 1 million pages of evidence.

The decision taken by Government Prosecutors, based on the

investigation findings and legal advice, is that there is no

realistic prospect of a conviction in this case, and that the case

should not proceed to criminal prosecution. The legislation in force

at the time was not sufficiently strong or comprehensive as to

require companies to inform the regulator of safety information when

the drug was being used for, or tested outside its licensed

indications.

GSK provided the MHRA with data from clinical trials in May 2003,

confirming that patients under 18 had a higher risk of suicidal

behaviour if they were treated with Seroxat than if they received a

placebo; and that Seroxat was ineffective in treating depressive

illness in under 18's. Acting upon this information the MHRA

immediately reviewed the data and published advice to all doctors

that Seroxat should not be used in under 18's. The investigation

arose from concern that GSK had held the information for some time

before this and failed to disclose it.

Professor Kent Woods, MHRA Chief Executive, said: " I remain concerned

that GSK could and should have reported this information earlier than

they did. All companies have a responsibility to patients, and should

report any adverse data signals to us as soon as they discover them.

This investigation has revealed important weaknesses in the drug

safety legislation in force at the time. Subsequent legislation has

partially addressed the problem, but we will take immediate steps to

ensure the law is strengthened further, so that there can be no doubt

as to companies' obligations to report safety issues. "

Notes to Editor

See website -

www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014

153 to download full report and related documents.

Download documents:

1. Press release: GSK investigation concludes Download Acrobat Reader

for free

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[Guest guest]

Press release

Date: 06 Mar 2008

Time: 09:30

Subject: GSK investigation concludes

Contact: Press Office 020 7084 3535/3564 or

press.office@...

Out-of-hours 07770 446 189

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON014152

The MHRA has concluded its four year investigation into

Glaxosmithkline and its antidepressant drug Seroxat. The

investigation focused on whether GSK had failed to inform the MHRA of

information it had on the safety of Seroxat in under 18's in a timely

manner. The investigation was undertaken with a view to a potential

criminal prosecution for breach of drug safety legislation. It was

the largest investigation of its kind in the UK, and included the

scrutiny of over 1 million pages of evidence.

The decision taken by Government Prosecutors, based on the

investigation findings and legal advice, is that there is no

realistic prospect of a conviction in this case, and that the case

should not proceed to criminal prosecution. The legislation in force

at the time was not sufficiently strong or comprehensive as to

require companies to inform the regulator of safety information when

the drug was being used for, or tested outside its licensed

indications.

GSK provided the MHRA with data from clinical trials in May 2003,

confirming that patients under 18 had a higher risk of suicidal

behaviour if they were treated with Seroxat than if they received a

placebo; and that Seroxat was ineffective in treating depressive

illness in under 18's. Acting upon this information the MHRA

immediately reviewed the data and published advice to all doctors

that Seroxat should not be used in under 18's. The investigation

arose from concern that GSK had held the information for some time

before this and failed to disclose it.

Professor Kent Woods, MHRA Chief Executive, said: " I remain concerned

that GSK could and should have reported this information earlier than

they did. All companies have a responsibility to patients, and should

report any adverse data signals to us as soon as they discover them.

This investigation has revealed important weaknesses in the drug

safety legislation in force at the time. Subsequent legislation has

partially addressed the problem, but we will take immediate steps to

ensure the law is strengthened further, so that there can be no doubt

as to companies' obligations to report safety issues. "

Notes to Editor

See website -

www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014

153 to download full report and related documents.

Download documents:

1. Press release: GSK investigation concludes Download Acrobat Reader

for free

Adobe text conversion tools

[Guest guest]

Press release

Date: 06 Mar 2008

Time: 09:30

Subject: GSK investigation concludes

Contact: Press Office 020 7084 3535/3564 or

press.office@...

Out-of-hours 07770 446 189

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON014152

The MHRA has concluded its four year investigation into

Glaxosmithkline and its antidepressant drug Seroxat. The

investigation focused on whether GSK had failed to inform the MHRA of

information it had on the safety of Seroxat in under 18's in a timely

manner. The investigation was undertaken with a view to a potential

criminal prosecution for breach of drug safety legislation. It was

the largest investigation of its kind in the UK, and included the

scrutiny of over 1 million pages of evidence.

The decision taken by Government Prosecutors, based on the

investigation findings and legal advice, is that there is no

realistic prospect of a conviction in this case, and that the case

should not proceed to criminal prosecution. The legislation in force

at the time was not sufficiently strong or comprehensive as to

require companies to inform the regulator of safety information when

the drug was being used for, or tested outside its licensed

indications.

GSK provided the MHRA with data from clinical trials in May 2003,

confirming that patients under 18 had a higher risk of suicidal

behaviour if they were treated with Seroxat than if they received a

placebo; and that Seroxat was ineffective in treating depressive

illness in under 18's. Acting upon this information the MHRA

immediately reviewed the data and published advice to all doctors

that Seroxat should not be used in under 18's. The investigation

arose from concern that GSK had held the information for some time

before this and failed to disclose it.

Professor Kent Woods, MHRA Chief Executive, said: " I remain concerned

that GSK could and should have reported this information earlier than

they did. All companies have a responsibility to patients, and should

report any adverse data signals to us as soon as they discover them.

This investigation has revealed important weaknesses in the drug

safety legislation in force at the time. Subsequent legislation has

partially addressed the problem, but we will take immediate steps to

ensure the law is strengthened further, so that there can be no doubt

as to companies' obligations to report safety issues. "

Notes to Editor

See website -

www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014

153 to download full report and related documents.

Download documents:

1. Press release: GSK investigation concludes Download Acrobat Reader

for free

Adobe text conversion tools

[Guest guest]

Press release

Date: 06 Mar 2008

Time: 09:30

Subject: GSK investigation concludes

Contact: Press Office 020 7084 3535/3564 or

press.office@...

Out-of-hours 07770 446 189

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON014152

The MHRA has concluded its four year investigation into

Glaxosmithkline and its antidepressant drug Seroxat. The

investigation focused on whether GSK had failed to inform the MHRA of

information it had on the safety of Seroxat in under 18's in a timely

manner. The investigation was undertaken with a view to a potential

criminal prosecution for breach of drug safety legislation. It was

the largest investigation of its kind in the UK, and included the

scrutiny of over 1 million pages of evidence.

The decision taken by Government Prosecutors, based on the

investigation findings and legal advice, is that there is no

realistic prospect of a conviction in this case, and that the case

should not proceed to criminal prosecution. The legislation in force

at the time was not sufficiently strong or comprehensive as to

require companies to inform the regulator of safety information when

the drug was being used for, or tested outside its licensed

indications.

GSK provided the MHRA with data from clinical trials in May 2003,

confirming that patients under 18 had a higher risk of suicidal

behaviour if they were treated with Seroxat than if they received a

placebo; and that Seroxat was ineffective in treating depressive

illness in under 18's. Acting upon this information the MHRA

immediately reviewed the data and published advice to all doctors

that Seroxat should not be used in under 18's. The investigation

arose from concern that GSK had held the information for some time

before this and failed to disclose it.

Professor Kent Woods, MHRA Chief Executive, said: " I remain concerned

that GSK could and should have reported this information earlier than

they did. All companies have a responsibility to patients, and should

report any adverse data signals to us as soon as they discover them.

This investigation has revealed important weaknesses in the drug

safety legislation in force at the time. Subsequent legislation has

partially addressed the problem, but we will take immediate steps to

ensure the law is strengthened further, so that there can be no doubt

as to companies' obligations to report safety issues. "

Notes to Editor

See website -

www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON014

153 to download full report and related documents.

Download documents:

1. Press release: GSK investigation concludes Download Acrobat Reader

for free

Adobe text conversion tools