27 October 2006 - E-mail response from Mr S. Fawbert, MHRA

From:          Fawbert, Stephen
Date:         27 October 2006 14:23
To:              [email protected]
Subject:     FOI 06/320

Dear Mr Medawar,
Thank you for your email of 28 September about pimozide and paroxetine.

Following the European referral for paroxetine, Seroxat is authorised through one of the European licensing procedures, the Mutual Recognition procedure with the Netherlands acting as lead European Member State.   The agreed European timetables for review of applications to vary the marketing authorisation coupled with the need to seek further information from the company in relation to some of the proposed changes will have dictated the timescale for completion of this variation to add a contraindication against concomitant use of pimozide to the product information for Seroxat.  During the assessment of this application to vary the Seroxat product information it was not considered that a Dear Doctor letter was warranted on this particular occasion. We did not consider that it was necessary for any specific urgent communications to be issued in the UK with regard to the addition of this new contraindication. In making this decision we took into account i) the fact that the pimozide product information contains extensive warnings about its potential to cause prolongation of the QT interval, ii) the contraindication that already existed in the pimozide SPC against its use in combination with drugs which inhibit cytochrome P450 2D6 such as Seroxat, ii) the low usage of pimozide in the UK and iv) that the contraindication against the use of pimozide in combination with some other SSRIs was already recognised.

The pimozide SPC will be updated to reflect the contraindication with paroxetine in due course.  Again, as I have said before, pimozide is not used widely in the UK so this change to the SPC will be made in line with routine regulatory updates.

You have asked for copies of communications about the concurrent use of pimozide and paroxetine between the Agency and GlaxoSmithKline between the Agency and GSK.  As paroxetine is licensed through the mutual recognition procedure, any correspondence regarding this application would have been between the Reference Member State (the Netherlands) and GSK.

Yours sincerely
Stephen Fawbert

Stephen Fawbert
Information for Public Health Group, VRMM
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-110
1, Nine Elms Lane

Tel: 020 7084 2788