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| 5th July 2002 | ||||
| Stockley Park West | ||||
| Uxbridge | ||||
| Middlesex | ||||
| UB11 1BT | ||||
| Tel. +44 (0)20 8990 9000 | ||||
| Fax. +44 (0)20 8990 4321 | ||||
| www.gsk.com | ||||
Mrs Heather Simmonds
Code of Practice Authority
12 Whitehall
London SW1A 2DY.
Case AUTH/1318/5/02 Safety of Seroxat (paroxetine)
Thank you for your letter of 2nd July 2002 requesting additional information with regards to the complaint made by Mr Charles Medawar on 20th May 2002 to the ABPI.
The additional information requested was:
The date when the Seroxat summary of product characteristics was amended to include the recommendations from the Committee for Proprietary Medicinal Products (CPMP). The confirmation of the dates that the briefing documents came into effect.
I will address each of these in turn.
Date when the Seroxat summary of product characteristics was amended
The amendment to the Seroxat Summary of Product Characteristics (SmPC) was approved by the
MCA in June 2001 and included in packs on the market from July 2001. Following the
recommendations of the CPMP the SmPC was supplemented (the SmPC already included a
paragraph on withdrawal symptoms before the CPMP recommendations were made) to include the
following additional statement "In common with other selective serotonin reuptake
inhibitors, withdrawal symptoms have been reported on stopping treatment. The available
evidence does not suggest these are due to dependence." This amendment was approved
in conjunction with a number of other changes to the Seroxat SmPC. These changes were a
result of a company review of Seroxat and a review of the SSRIs by the MCA.
Dates then the briefing documents came into effect
The dates on the briefing documents of 6th
September and 19th December correspond
to the final ABPI approval dates and these documents were therefore available for use from
those dates onwards. Consequently the briefing document available in October for use in
responding verbally to media enquiries was the version approved on 6th September.
I hope this has covered all the additional information you have requested.
Yours sincerely
E Gray
General Manager and Senior Vice President
