Department of Health
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737 .
10 December 1998

Dear Mr Medawar,


Your further letter of 23 November refers.

I am grateful for the trouble you have taken to scrutinise the data sheets and compare them with the warning in the BNF. Such statements represent the opinion of the Joint Formulary Committee and its experts, and not necessarily those of the Licensing Authority. It is not unprecedented for advice in the BNF to differ from authorised product information, though we seek at all times to ensure there are no significant discrepancies.

As I believe you are aware, product information is authorised at the time of approval, reflecting the data presented in the application. Subsequent changes to such information can be at the request of the. holder of the marketing authorisation or the Licensing Authority via the MCA.

The MCA routinely monitors safety and ADR data obtained from a variety of sources including spontaneous reports and published information. We evaluate information which may suggest a previously unrecognised safety issue, taking expert advice wherever necessary. We then ensure that the marketing authorisation holder makes any changes to the product information which are needed.

To date, routine safety monitoring has not indicated that the product information relating to neuroleptics and withdrawal needs amendment. Nonetheless we have begun to review the evidence following your letter. An important part of our review will be the published paper by Tranter & Healy. I do not believe there is a need for the MCA to take action before then but, as I previously explained, we will comment further, if necessary, once that report is published.

Yours sincerely
Roy Alder for Dr K. Jones
Director and Chief Executive


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