Fwd: [SSRI-Research] Very Important Information from the UK regarding Paxil ADRs

[Guest guest]

JustSayNo

Thu, 20 Nov 2003 10:01:33 -0500

[sSRI-Research] Very Important Information from the UK regarding Paxil

ADRs

 

FYI:

 

The Yellow Card Reporting System in the United Kingdom is comparable to the

MedWatch Reporting System here in the United States

 

" Charles Medawar "

Analysis of paroxetine Yellow Card adverse drug reaction reports

(Seroxat/Paxil)

Wed, 19 Nov 2003 20:05:47 -0000

 

I have just posted on our website a copy of a paper on this subject

published today in the International Journal of Risk and Safety of Medicine.

See http://www.socialaudit.org.uk/5100what.htm#5.1

This paper (Medawar & Herxheimer, 2003) is the first

analysis of its kind: it reveals new information both about paroxetine

and the Yellow Card drug safety system. A summary of the main

points appears below:

 

International Journal of Risk & Safety in Medicine 16 (2003/2004) 5-19

 

A comparison of adverse drug reaction reports from professionals and users,

relating to risk of dependence and suicidal behaviour with paroxetine

 

Charles Medawar (Social Audit Ltd., London, UK) and Andrew Herxheimer FRCP

(DIPEx Project, Department of Primary Health Care, University of Oxford,

Oxford, UK)

 

Summary points

 

1. This report is unique in two different ways:

 

· It is the first published critical appraisal of the role of

spontaneous adverse drug reaction (ADR) reports in monitoring the safety of

marketed medicines - the MHRA/CSM Yellow Card scheme is regarded " as the

cornerstone of the Agency's work on medicines safety monitoring. "

 

· This is also the first review of anonymised Yellow Card reports of

suspected adverse drug reactions to paroxetine, relating to withdrawal

reactions/dependence and suicidal behaviour. This report compares the value

of ADR reports from drug users and health professionals.

 

2. This report produces new evidence of several different kinds:

 

· It suggests that miscoding and flawed analyses of Yellow Cards have

led to under-estimation of the risk of suicidal behaviour;

 

· It reveals that most Yellow Cards lack important information (e.g.

patient history, dosage; outcome of reaction);

 

· It shows that the UK regulators have systematically failed to

follow up reports of suicidal behaviour, in spite of conducting several

reviews;

 

· It suggests that poor reporting and data processing have impeded

recognition of what appears to be a close relationship between suicidal

behaviour and changes in drug concentration. An increased risk of suicidal

behaviour during the first few days of treatment with an SSRI has long been

suspected - but comparable risks seem to exist when drug dosages are either

increased or lowered (during withdrawal).

 

· It suggests that SSRI dosages may be far too high for some users

 

· It gives evidence that ADR reports sent in by drug manufacturers

systematically use euphemisms in describing ADRs (e.g. 'Non-accidental

overdose' to describe suicide attempts) that help to obscure the true nature

of risk;

 

3. We suggest that, although the Yellow Card is widely recognised as one of

the best in the world it is, in important respects, " chaotic and

misconceived " . Its value is limited by the emphasis on numbers not words;

the focus on rare and 'interesting' ADRs, rather than the generality of

drug-induced problems; secrecy that obstructs wider access to anonymised

data; and lack of input from drug users themselves.

 

4. Our analyses suggest that reports from patients - in their own words -

communicate essential information which professional reporters can never be

expected to provide. We believe that patient reports of suspected ADRs can

never credibly be ignored again.

 

5. We have submitted this and other evidence to the on-going review of the

Yellow Card Scheme, under Dr Jeremy Metters of the UK Department of Health.

 

I hope this is of interest

 

Charles Medawar

Social Audit Ltd

P.O. Box 111

London NW1 8XG UK

TEL/FAX +44 (0)20 7586 7771

http://www.socialaudit.org.uk

 

 

 

 

 

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