By email only to jeremybryce1953@...
source - http://health.groups.yahoo.com/group/criticalpsychiatry2/message/9862
FOI 09 086
9 April 2009
Dear Mr Bryce
Thank you for your Freedom of Information Act (FOIA) request of 12 March. As this is for Vigilance and Risk Management of Medicines Division it has been passed to me for reply.
You have asked which makers of antidepressants received a request to include the following statement in product information:
"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."
The following companies were contacted:
Pfizer Limited
Solvay Healthcare Limited
SmithKline Beecham Pharmaceuticals
Lundbeck Limited
Eli Lilly and Company Limited.
Please find the text of letters sent to the companies attached. I have removed names of MHRA staff under S38 FOIA (health and safety) and information that could identify a third party under Section 40 (personal information).
All the companies updated their product information to include this wording by submitting a variation.
If you have a query about this letter, please contact me. If you are unhappy with our decision to withhold certain information, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at
The Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.
Yours sincerely
Stephen Fawbert
source - http://health.groups.yahoo.com/group/criticalpsychiatry2/message/9862
FOI 09 086
9 April 2009
Dear Mr Bryce
You have asked which makers of antidepressants received a request to include the following statement in product information:
"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."
The following companies were contacted:
Pfizer Limited
Solvay Healthcare Limited
SmithKline Beecham Pharmaceuticals
Lundbeck Limited
Eli Lilly and Company Limited.
Please find the text of letters sent to the companies attached. I have removed names of MHRA staff under S38 FOIA (health and safety) and information that could identify a third party under Section 40 (personal information).
All the companies updated their product information to include this wording by submitting a variation.
If you have a query about this letter, please contact me. If you are unhappy with our decision to withhold certain information, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference. After that, if you remain dissatisfied, you may ask the Information Commissioner at
The Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.
Yours sincerely
Stephen Fawbert
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