Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 020 7 273 0267
Facsimile 020 7  273 0109 .
Our ref SK/seroxat.vmbO32000
12 July 2000

Dear Mr Medawar,

RE: SEROXAT ADVERTISEMENT

I refer to your letter of 23 March 2000 to Mrs Hopkins concerning an advertisement for Seroxat which was published in the General Practitioner on 17 March 2000,

We have looked into your complaint that the advertisement breaches Regulation 3A(2) of Advertising Regulations (advertisement must encourage the rational use of the product by presenting it objectively and without exaggerating its properties). We have reviewed the following data as part of our assessment:

1 . . De Wilde J et al. Acta Psychiatr Scand 1993; 87: 141-5
2. Chouinard G et al. J Affective Disord 1999. 54: 39-48.
3. Geretsegger C et al. Int Clin Psychopharmacol 1994; 9: 25-9
4. Dunbar GC et al. Acta Psychiatr Scand 1993; 87: 307-5.
5. Dunbar GC et al. Br J Psychiatry 1991; 159: 394-8.
6. Ontiveros A, Garcia-Barriga C.Br J Clin Res 1997; 8: 23-32.
7. Tignol J. J Clin Psychopharmacol 1993; 13 (6) Suppl 2: 18S-22S.
8. Shrivastava RK et al. Presented at 146h Annual Meeting of the American Psychiatric Association. San Francisco 22-27th May 1993.
9 Edwards JG, Anderson J. Drugs 1999. 57 (4): 507-33.
10. Kaye CM et. al..Acta Psychiatr Scandl989;80(Suppl350):60-75
11. Fluoxetine Data Sheet..
12. Lane R et al. J Psychopharmacol 1995; 9 (2 Suppl): 163-78

Our conclusion is that the data supports the claim "Lifts mood quicker than fluoxetine". Even though not all the studies provide comparative data with fluoxetine and some comparative studies with fluoxetine did not show statistically significant differences in terms of onset to action, the overall balance of evidence is in favour of the claim. This includes evidence from meta-analyses (Edwards & Anderson 1999) and pharmaco-kinetic considerations. We do not, therefore, consider that it is necessary to take any action in relation to this advertisement.

Thank you for bringing this to our attention. 

Yours sincerely
MRS JAN MACDONALD
Head, Product Information & Advertising
Post Licensing Division

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