Social Audit Ltd

P O Box 111 London NW1 8XG

Telephone/Fax 44 (0)171 586 7771

Dear Sirs,

I am undertaking some preliminary research into the treatment of depressive illness. It would help me in this if you could provide me with full prescribing information for SEROXAT tablets (paroxetine).

For the record, I am not medically qualified but a specialist in drug policy and safety issues. I hold or have held a number of appointments relating to such work, eg with World Health Organisation, Drug & Therapeutics Bulletin and US Pharmacopoeial Convention Inc., and would be pleased to provide further information if you require it.

Yours faithfully,

Charles Medawar

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Social Audit Ltd

P O Box 111 London NW1 8XG

Telephone/Fax 44 (0)171 586 7771

Dear Ms Jones,

I recently wrote to you in connection with some preliminary research I am undertaking into the treatment of depressive illness to ask if you could provide me with full prescribing information for SEROXATÔ tablets (paroxetine). I am grateful to you for sending me a copy of the data sheet/SPC, and am now writing to ask if you could please give me information on one or two questions arising - and/or let me have let me have a copy of the product monograph, where I might expect to find at least some of the answers.

1. Please could you give me a citation to the placebo-controlled trial demonstrating the efficacy of paroxetine for up to one year, which is mentioned in the 1996 US label (though not in the data sheet/SPC)

2. The 1996 US label (though not the data sheet/SPC) mentions that paroxetine has not been systematically studied in animals or humans for dependence potential. Could you please confirm that this is still the case, or otherwise refer me to any such studies that have now been done ?

3. Has the company carried out any studies (including surveys) which might throw light on the incidence and clinical significance of withdrawal reactions (whether after abrupt or tapered discontinuation) mentioned in the UK data sheet and, if so, please could you refer me to them ?

4. Headache is not mentioned as an adverse event in the UK data sheet, though the US Label 1996 mentions that it was reported by 17.6% of patients in pre-marketing placebo-controlled trials. The reason would appear to be that the same adverse effect was reported by 17.3% of patients on placebo - but should I then infer that the severity of headache on active drug was comparable to that on placebo ? Indeed was the severity of this and other adverse effects on placebo and active drug actually measured ?

Thank you for your attention and I shall look forward to hearing from you.

Yours sincerely,

Charles Medawar

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