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Mr S. Fawbert
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

3 November 2006


Dear Mr Fawbert,

I am replying to your email of 27 October, your response to my FOI request (06/320) of 28 September, in which I asked why the MHRA appeared to do so little, and to act so late, in advising UK prescribers that concurrent use of paroxetine+pimozide was contraindicated.

I shall shortly be posting to our website an editorial note, that comments on your response in more detail. Also, later next week, you will be receiving, with our compliments, a copy of Sir Ernest Gowers’, Complete Plain Words. Enjoy.

In the meantime, I seek to establish how the MHRA actually arrived at the decision you explained: "it was not considered that a Dear Doctor letter was warranted on this particular occasion". The aforementioned editorial note (still in draft) records my thought that, "It would be reassuring – could even be impressive – if the paper trail showed that the MHRA actually did recognise the risks, and took the inaction they decided upon, only after carefully weighing up the pros and cons." You are welcome, of course, to provide any documentary evidence you think might impress but, in any case, please treat the following as FOI requests:

1. Please provide documentary evidence to show that the MHRA had, prior to September 2006, formally considered [a] whether and how to alert UK prescribers to the new contraindication (paroxetine+ pimozide), other than by means of a small print change in the SPC; and [b] any or all of the four reasons you gave me for deciding to take no action.

I don’t want to make this a burdensome request and would be happy to receive any one document (covering both [a] and [b]) on which the Agency might chose to rely.

Perhaps you could also clarify these points:

2. Did the fact that this matter was being handled through the European drug approval system preclude (effectively prohibit or inhibit) unilateral action by the Agency? In other words, could the MHRA have requested GlaxoSmithKline (and have expected compliance from them) to either take, or agree to, more effective measures to communicate this label change?

3. Please would you explain why the contraindication for pimozide is not referred to in the current SPC for fluvoxamine (taking into account that such a warning has appeared in the US label since June 2000)? Ditto citalopram and escitalopram (US warnings since January 2005).

4. Does the Agency not accept that the warning in the pimozide SPC – which lists some SSRIs but which excludes paroxetine - is misleading and potentially dangerous – and if not, why not?

Please feel free to comment on any other points raised in my editorial note. I look forward to hearing from you.


Charles Medawar                                                 cc Mr R Goldfinch


The point of these questions is further explained in the attached EDITORIAL NOTE