INFOFAX

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FROM/EXPEDITEUR: DR S WOOD             DATE: 19/12/1997

UK Medicines Control Agency          Pages (including cover sheet) 2

SUBJECT/OBJET:

Brand name: PROZAC, SEROXAT, FAVERIN, LUSTRAL, DUTONIN, EFEXOR

INN/DCI: FLUOXETINE, PAROXETINE, FLUVOXAMINE, SERTRALINE, NEFAZODONE AND VENLAFAXINE

REASON FOR ALERT/RAISONS DE L'ALERTE:

A discussion paper by Medawar on the treatment of depression called 'The Antidepressant Web' has been published in International Journal of Risk & Safety in Medicine 10 (1997) 75-126. In this paper Medawar questions the efficacy of antidepressant drugs and claims that selective serotonin reuptake inhibitors (SSRIs) are drugs of dependence.

PROPOSED ACTION AND ACTION TAKEN/MESURES ENVISAGEES ET MESURES PRISES:

We are reviewing evidence that SSRIs (paroxetine, fluoxetine, sertraline, fluvoxamine and citalopram) and related antidepressants (venlafaxine and nefazodone) produce withdrawal reactions and dependence. We propose a preliminary discussion at the Pharmacovigilance Working Party in January. A brief report, including the published paper will be sent to you shortly.

We would be grateful if you could provide the following information:

1. Which SSRIs and related antidepressants do you have on the market?

2. What warnings are present in the product information with regard to withdrawal reactions and dependence?

3. How many cases of withdrawal reactions and dependence associated with SSRIs and related antidepressants have been reported in your country?

4. The level of usage of these drugs.

Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0763
Facsimile 0171- 273 0675	22 December 1997

Dear Sir/Madam

We are carrying out a review of the SSRIs and related antidepressants m order to ensure that the marketing authorisations and product information adequately reflect Post-marketing experience with these drugs and to identify class effects and standardise product information where appropriate.

Following the publication of a discussion paper on the treatment of depression 'The Antidepressant Web' by Charles Medawar (International Journal of Risk & Safety in Medicine 10 (1997) 75-126), we would like you to comment on the conclusions in this paper in relation to the safety and efficacy of your product.

A particular focus is the issue of withdrawal reactions associated with these drugs. Please would you provide any unpublished data relating to whether or not paroxetine has been associated with features of dependence including physiological withdrawal symptoms. We request a report containing any relevant case reports and studies, a conclusion as to whether you consider paroxetine causes dependence, and comments on the adequacy of the existing product information.

The deadline for this information is 23 January 1998. I appreciate that this is a short deadline in view of the Christmas holiday, however it is important that all the relevant data is collected as soon as possible.

Thank you in advance for your help in this matter. If you have any queries, please do not hesitate to contact me.

Yours sincerely

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