Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, August 01, 2008

'Duff Withdrawal Advice' from Chairman of the CSM


Who are/were the CSM?

The Committee on the Safety of Medicines (CSM) was an independent advisory committee that for 40 years advised the UK Licensing Authority on the quality, efficacy and safety of medicines. It was replaced on 30 October 2005 by the Commission on Human Medicines which combines the functions of both the former committee and the Medicines Commission.


In 2003, Professor Gordon Duff, the then Chairman of the Committee on Safety of Medicines, sent out an URGENT transmission regarding new evidence relating to the efficacy and safety of
Seroxat (paroxetine) in children and adolescents under the age of 18 years when used to treat depreesive illness.


Included in this transmission was Duff's 'expert opinion' on tapering.


He writes:


Seroxat should not be stopped suddenly because of the risk of withdrawal reactions. The dose should be reduced very gradually, using half tablets, and then alternating days, if necessary. If the dose is not tapered, there is a greater chance of experiencing side effects. For the majority of people, symptoms go away on their own within 2 weeks. If side effects are intolerable on dose reduction or stopping, the dose should be increased and subsequently reduced more gradually.



The dose should be reduced very gradually, using half tablets, and then alternating days, if necessary?


Is this the guidance that the MHRA followed?


Is it any wonder that there are so many people struggling with withdrawal problems when tapering off Seroxat when the Chairman, who considers himself an expert in these matters, offer advice like this?


Duff advice indeed!


Maybe Duff should have told these people that the way to slowly taper is by cutting a tablet in half then alternating days.


It's just another classic example of how the 'experts' got it wrong and how the patients pleas once again went unheard... or as I prefer to label it [ignored] by the regulator!


It's time for change.


It's time for the regulator to not only listen to us but to act on what we have to say. I will continue banging the drum until they show some willing and start believing.



Fid





Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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