The “Addiction” Issue & Hugh James’ need to change the Patient Information Leaflet (PIL)

Patient safety, accurate honest comprehensive information, instructions and warnings to enable patients to make informed choices about treatment is and should be paramount in any discussions with regard literature issued to patients and primary health care providers.

"A product is defective if, at the time of circulation, it is not as "safe as persons generally are entitled to expect," taking account of a number of factors including any instructions or warnings provided with the product and the manner in which it has been marketed. “

Access my Library: Mass tort treatment pharmaceutical

"Mark Harvey, solicitor for the Seroxat Users Group, told BBC News Online: "We would welcome the removal of the suggestion that the drug is not addictive."

BBC: Seroxat safety advice to be changed

"Message from Mark Harvey, Hugh James Solicitors ………
c) For the first time in the 13 years of this drug, the manufacturers have agreed to change the Patient warning sheets to deal with the question of addiction."

Hugh James Solicitors

The Seroxat Patient Information Leaflets (PIL) was predominant in the Seroxat Group Litigation Solicitors and Seroxat User Groups discussions and media coverage, as Mark Harvey of Hugh James Solicitors confirms in the above quotes.

The first of two changes to the SSRI PILs only related to the GSKs Seroxat, the addiction issue and the sentence 'Remember that you cannot become addicted to Seroxat' which was removed from the document in 2003 – an action that Mark Harvey of Hugh James and the Seroxat User Groups took and deserved full credit for – although an empty platitude.

Removal of the Seroxat “addiction” sentence from the PIL was not an admission of guilt – i.e. by doing this GSK were not saying that you could become addicted to Seroxat - although this was the inference in any reports made by or on behalf of those accredited for the action.

Unfortunately bringing the “addiction” issue to the notice of the UK licensing authorities the MHRA in 2002 brought no change to The World Health Organization’s (WHO) criterion for addiction, therefore Seroxat and all SSRI, SNRIs remain outside that ruling - despite considerable discontinuation problems.

Had the “addiction” issue been upheld and / or the WHO criterion for addiction changed to encompass any discontinuation problems – the Seroxat Group Litigation would have been proved on “Failure to Warn” in marketing “instructions and warnings” provided with the product.

In real terms the GSK statement 'Remember that you cannot become addicted to Seroxat' although removed from the PIL - still stands – however, GSK, the MHRA and WHO have all been seen to listen to patients complaints & concerns - and have been seen to act promptly on their behalf in a professional & responsible manner.