|Department of Health|
|MEDICINES CONTROL AGENCY|
|Market Towers 1 Nine Elms Lane London SW8 5NQ|
|Telephone 020 7273 0100/0546|
|Facsimile 020 7273 0548||.|
|Dr David Healy, Director|
|University of Wales College of Medicine|
|North Wales Department, Hergest Unit|
|Ysbyty Gwynedd, Bangor, Gwynedd, LL57 2PW||8 June 2001|
Dear Dr Healy,
RE: SSRIs and the risk of suicide
Thank you for your letter of 4 April 2001 and for your fax of 7 June 2001.
We have reviewed the studies that you have referenced. These provide evidence that sertraline and paroxetine may be associated with CNS activation. I would like to point out that agitation is listed as an adverse effect in the Summaries of Product Characteristics of all SSRIs.
Thank you for informing us about your lecture in Toronto and for taxing us a copy of the lecture. Your letter of 20 December enclosed posters relating to your healthy volunteer study. As discussed at our meeting in December 2000, we are very interested to receive the full report of this study and would be grateful if you would confirm when this will be available.
Your fax of 7 June outlines your views on the recent court case in the USA. The Committee on Safety of Medicines (CSM) will be considering data from volunteer studies involving SSRIs in July 2001. We would be very interested to receive any data from the recent trial in the USA that you consider would be relevant for CSM to consider.
Yours sincerely Dr June Raine Director of Post-Licensing
CLICK HERE TO READ ON
Or HERE for full index of this correspondence