Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
TEL:  020 7273 0400
FAX:  020 7273 0675	.Our Ref: OG/0240
	13 November 2002

 

Dear Mr Medawar,

Paroxetine: withdrawal symptoms and dependence

Thank you for your further letter of 12 October 2002 in relation to Seroxat. I will take your questions in turn.

‘There have been isolated reports of more serious symptoms on withdrawal...’
The statement in the MCA response to Panorama in relation to ‘serious symptoms’ of withdrawal reactions is taken from a review of the spontaneous data and published case reports. Seriousness and severity have different meanings in the context of drug regulation. The majority of symptoms described on withdrawal of SSRIs are not symptoms that we would consider serious — by which we mean potentially life threatening or leading to significant disability. Severity relates to the intensity of a reaction, which in itself may or may not be serious. We would not consider headache to be a serious reaction per Se, however individuals may experience a severe headache. I hope this clarifies the issue for you.

Further studies to estimate the frequency of withdrawal reactions
A number of studies examining withdrawal reactions with SSRJs have been published since the CSM met in 1998. The expert meeting in November will be considering the currently available data and the need for further studies in this area.

CPMP Position on SSRIs and dependence
You ask whether the MCA statement in relation to the CPMP position is compatible with the CPMP position paper. We do not consider that the absence of evidence of a problem indicates the absence of a problem, in relation to this particular safety issue or any other. The reference to the CPMP in the MCA response to Panorama was meant to be a brief summary of the CPMP position. It is certainly not our intention to misrepresent the published position of the CPMP on this matter or to mislead the public. Our continued review of this issue is evidence that we remain open to new scientific data and analyses.

Definitions of dependence
As you are aware we will be revisiting the definitions of addiction and dependence during the expert meeting later this month. We have not formally sought the views of patients or prescribers on this issue.

Thank you for the update on your case against GlaxoSmithKline’s promotion of Seroxat. Once the Prescription Medicines Code of Practice Authority publishes the reasons for its decision we will consider what action, if any, is necessary.

We will of course ensure that your latest letter is considered by the expert meeting.

Yours sincerely

DR J M RAINE,

Director, Post-Licensing Division

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