Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
TEL:  020 7273 0400	3rd July 2002
FAX:  020 7273 0675	.

Dear Mr Medawar,

SEROXAT AND WITHDRAWAL REACTIONS

Thank you for your letter of 1 June 2002 to Dr Jones on the subject of Seroxat (paroxetine), withdrawal reactions and addiction. I have been asked to respond as monitoring the safety of medicines falls within my remit.

We have carefully noted the points you make about the definition of addiction and dependence, the current product information for Seroxat and the importance of the information received directly from patients. We will seek advice from CSM experts on the concerns you have raised and on the extracts from your website, and will feed back to you as soon as we can.

I will respond to your other questions individually.

1.        I enclose ADROIT drug analysis prints for the substances requested and information sheets to aid interpretation of the prints.

2.        The data from the WHO is consistent with that from the UK Yellow Card Scheme in that      venlafaxine and paroxetine have the highest number of reports of withdrawal reactions associated with them. These data are consistent with other sources which suggest a greater risk of withdrawal reactions with venlafaxine and paroxetine than with other medicines.

3.        The information you request on the drugs associated with the greatest number of reports of  withdrawal reactions on the ADROIT database is attached at Annex 1.

5.     The MCA/CSM had not previously made a systematic assessment of reports of withdrawal reactions associated with SSRIs directly from patients or their relatives. However we have  recently received, and are currently assessing, data from the MIND patient reporting scheme through which patients on psychiatric drugs were encouraged to report their experiences to MIND. As you are aware, we do not systematically collect reports from patients through the Yellow Card Scheme,

6.    The reference to ‘one or two reports’ of withdrawal reactions in the sentence that you quote is not consistent with the evidence from spontaneous reporting of the number withdrawal reactions reported with paroxetine. We recognise the public health importance of the withdrawal reactions associated with SSRIs and have communicated with prescribers on a number of occasions, via articles in Current Problems in Pharmacovigilance.

9.    The MCA website already has an e-mail address. While this is primarily designed as way of requesting information, we do receive reports of suspected adverse reaction from patients through this address. As mentioned previously, we are current looking at ways in which we can capture reports of suspected adverse reactions medicines directly from patients. It is, however, vital that patients who suspect that they may be suffering from an adverse reaction to consult their doctor in the first instance in order that they receive the appropriate advice and treatment without delay. It is important that any patient reporting scheme does not interfere with this important consultation.

10.    As indicated above, your letter and user comments will be circulated to members of CSM for their consideration and advice. Our response on points 4, 7 and 8 will follow after this.

Yours sincerely

DR J M RAINE,

Director, Post-Licensing Division

Rm 1029MT

Extn 0400

Fax 0675

CLICK HERE TO READ ON

Annex 1

The Top 20 medicines associated with reports of suspected withdrawal reactions
on the  UK ADROIT  database (See CSM/MCA Guidance on interpretation)

Drug substance	Number of UK reports of withdrawal reactions
PAROXETINE	1281
VENLAFAXINE	272
TRAMADOL	117
FLUOXETINE	91
SERTRALINE	81
CITALOPRAM	49
ZOPICLONE	44
LORAZEPAM	38
FENFLURAMINE	28
DIAZEPAM	24
NITRAZEPAM	21
BUPRENORPHINE	19
BUPROPION	18
CIMETIDINE	18
CLOMIPRAMINE	18
AMITRIPTYLINE	15
BACLOFEN	15
TRIFLUOPERAZINE	14
CLOZAPINE	13
FLUVOXAMINE	13
MIRTAZAPINE	13

 

	Contents page
	List of correspondence with MCA/CSM