Bob Fiddaman's meeting with top Civil servants @ the MHRA

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Guidance on the Management of Withdrawal from

Seroxat (Paroxetine) and Other SSRIs

Notes of a meeting held at MHRA on 2 September 2008

Present:

Robert (Bob) Fiddaman (RF), Campaigner, Author of Seroxat Sufferers Blog

Prof. Kent Woods (KW), Chief Executive, MHRA

Sarah Morgan (SM), Head of Pharmacovigilance Risk Management, MHRA

John Watkins (JW), Communication Manager, MHRA, acting as secretary

1. RF said he would like to discuss problems of withdrawing from Seroxat. He said that though his concerns centred around Seroxat, he recognised that other SSRIs posed similar problems which ought also to be addressed.


2. He produced copies of the Patient Information Leaflet (PIL) for Seroxat in which he had highlighted the 32 places where patients were told to talk with their doctor about various issues. He felt that too much of an onus was put on doctors, many of whom did not know enough about withdrawal problems and their management.


3. In answer to a question from KW, RF agreed that the focus of the meeting should be on the information going to doctors and perhaps also on their training.


4. KW noted that doctors do not generally refer to the PILs, nor indeed to the similar but more technical Summaries of Product Characteristics (SPCs). Instead, they use the British National Formulary (BNF), revised twice each year, and guidance produced by NICE. The NICE guidance on the management of depression was currently being revised; a draft is due to go out for public consultation in December 2008 with a view to publication in June 2009.


5. He emphasised that MHRA controls neither the BNF nor NICE in any of the matters they cover, but the Agency can and does make suggestions to both organisations about the information they provide.


6. RF illustrated the practical problems encountered by patients in withdrawing. He offered each of the others a jelly baby and asked them to bite off one-third. No problem. He then produced some Tic-Tacs (mints). It was immediately acknowledged that biting off a third was very difficult. Likewise with a Seroxat tablet, said RF. The liquid preparation was much better suited to dose tapering but doctors seemed largely unaware of it. He outlined his own experience of withdrawing over a period of 21 months. The liquid, administered through a syringe, helped that process, though – for him – not even tapering took him beyond the point where he felt he had to "go cold turkey". He did that because he did not want the drug to continue to have a hold over him.


7. During withdrawal he experienced severe "zaps" in his brain. He described his dependence on the drug as an addiction, and exemplified that by relating his feelings of wanting to "rip the shop apart" if it turned out that they were out of stock.


8. KW noted that the term "addiction" ought to be reserved for circumstances which typically entailed cravings leading to increase in dosage, but suggested it was less important to argue about terminology than to acknowledge, as he did, that there are significant problems associated with withdrawal; the issue was how best to manage withdrawal. He noted that, as with benzodiazepines, those SSRIs which both act and disappear more quickly are more likely to pose problems with withdrawal. He did not know whether a switch to slower acting SSRIs had been researched as a potential solution, as it had proved to be for benzodiazepines.