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Monday, January 05, 2009

Medicines Control Agency - Volume 26 Sept 2000

Current problems in Pharmacovigilance is produced by the Committee on Safety of Medicines [CSM] and the Medicines Control Agency. [MCA, Now MHRA]

Editorial Board: Professor AM Breckenridge, Professor M Kendall, Dr JM Raine, Dr PC Waller, Dr P Arlett, Mrs L Henderson.

SELECTIVE SEROTONIN REUPTAKE INHIBITORS [SSRi's]

Drug Withdrawal Reactions

In 19931 we alerted prescribers to the possibility of withdrawal reactions occurring with paroxetine. Spontaneous reports of suspected withdrawal reactions for the 5 SSRis, and for the related antidepressants venlafaxine and nefazodone, have been analysed.

There have been 1,625 reports of withdrawal reactions associated with SSRis and related antidepressants out of a total of 24,233 reports of suspected adverse reactions received through the Yellow Card Scheme for these drugs. The numbers of reports for withdrawal reactions for individual drugs varies considerably, accounting for between 1% and 15% of the total reports received. Paroxetine has been associated with the greatest number of spontaneous reports of withdrawal reactions.

PDF HERE

Let's take a look at a couple of members on the editorial board.

Professor AM Breckenridge has gone on record as saying, "The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish.”

"So called scandal"?

Here we have a report, that Breckenridge played a huge part in compiling, that clearly states that paroxetine [Seroxat] has been associated with the greatest number of spontaneous reports of withdrawal reactions and yet Breckenridge wants to 'nail' the so called Seroxat scandal?

Some years later, Breckenridge went on national TV and defended Seroxat, his performance on BBC TV's Panorama can be seen below.

Alastair Breckenridge, resigned his position on Glaxo's scientific advisory committee to take up his previous position as chairman of the CSM.

While he was still on GSK's advisory board Professor Breckenridge took part in the Seroxat licensing discussions.

And what of June Raine? She was also part of the editorial team for this report.

Professor David Healy wrote to Raine in June 2000. Part of his letter read:

"I think what will also be clear is that SmithKline Beecham recognised the presence of withdrawal syndromes in their volunteers from the early to mid 1980s. That withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines. Nevertheless they applied for and have received from you and other regulators a licence to claim that their drug is effective in the prophylaxis of depression and these claims have been based on designs which almost certainly are designs better suited to show the presence of a withdrawal syndrome than designs suited to demonstrate prophylaxis in depressive disorders. A great number of people have in recent years been told that when they begin to feel ill on discontinuing treatment that this is the recrudescence of their mood disorder rather than a discontinuation syndrome from their drug. I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I’ve been faced with."

June Raine did nothing, despite being part of the editorial team that produced this report some three months later!

So here we are... now in 2009. During the past 9 years there have been four Panorama programmes highlighting the dangers of Seroxat. The MHRA have held talks with myself and Janice Simmons of the Seroxat User Group. The Yellow Card Scheme, which they seem to be immensly proud of, now reads 10,339 adverse reports for Seroxat.

Now one has to bear in mind here that the total number of yellow cards sent to the MHRA are not a true figure of the problems face with this particular SSRi. Some circles suggest that the MHRA receive maybe 10% of actual adverse drug reactions. If that figure is true then we can put the total number of adverse reports for Seroxat closer to 100,000.

Seroxat is not the only SSRi with withdrawal problems. There are many others [if not all] that have major problems when tapering. Day after day patients are returning to their doctors with complaints of dizziness, fatigue, zaps, aggression. Take away the zaps and you have classic depression symptoms. So the doctor re-prescribes the patient the SSRi they were originally on. And so the cycle continues.

As promised, here is Alasdair Breckenridge 'performing' on 'Taken on Trust', a documentary from the BBC Panorama team. It was aired in 2004, some 4 years after the Current problems in Pharmacovigilance I have highlighted in this post. Pay particular attention around the 3.26 mark.





Fid



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

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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