Dear MHRA... Is Seroxat addictive?

Read on for the MHRA's position on whether Seroxat is addictive or not.

On the 15th December 2007 I wrote to the MHRA. It was a brief email and asked one simple question.. Is Seroxat addictive?

Basically, I pretty much knew what their answer would be - I just didn't expect to have to go round the houses before they finally acknowledged their position on Seroxat. Only 4 emails but hey what do you expect from them!


----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Saturday, December 15, 2007 7:04 AM

Subject: Dear Sirs

Simple question that merely requires a yes or no answer. This shouldn't take 20 working days to answer.

Is Seroxat addictive?

Regards

Bob Fiddaman

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----- Original Message -----
From: MHRA Information Centre
To: fiddaman
Sent: Thursday, December 20, 2007 10:15 AM

Subject: RE: Dear Sirs

Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA.

The Agency's position, informed by expert advice, on whether Seroxat is addictive has been clearly communicated in the report of the CSM Expert Working Group on the Safety of SSRIs - this report is available on the MHRA website at the below link:

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=242

Please contact me again if you need further assistance with this, or any other queries.
Kind Regards,

Central Enquiry Point Information Centre Medicines and Healthcare products Regulatory Agency Tel: 020 7084 2000

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----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Thursday, December 20, 2007 2:32 PM
Subject: Re: Dear Sirs
Dear Sir/Madam,

Could you point me to the paragraph where an official MHRA statement has been made as to whether Seroxat is addictive or not.

I have trawled through the paper and cannot see any such statement. Maybe I'm missing something?

As you are aware GlaxoSmithKline have now realeased the European Promotion of Medicines Code of Practice 2nd Edition 2007 in which it states on page 6 (clause 4 - 4.10) "It must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency."

If the MHRA say Seroxat isn't addictive (I don't know whether you have because I can't find any official statement) then do they (MHRA) still stand by this comment?

Basically, this email is a follow-up to my original question of whether the MHRA think Seroxat is addictive.

1. I cannot find any official MHRA statement in the link you sent me, please point me to the paragraph and

2. If the MHRA have stated in the past that Seroxat is not addictive, do they still stand by this, given the European Medicine of Medicines Code of Practice 2nd Edition 2007 clearly states that it must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency?

Meantime, I look forward to you reply

Regards

Mr Robert Fiddaman.

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----- Original Message -----
From: MHRA Information Centre
To: fiddaman

Sent: Monday, December 31, 2007 11:39 AM

Subject: RE: Dear Sirs

Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA. The risk of dependence (addiction) and withdrawal reactions in associations with Seroxat and others SSRIs was covered in Chapter 8 - pages 119-157 and is also covered in the executive summary pages 3-4 of the report.

Please contact us again if you need further assistance with this, or any other queries.


Kind Regards,

Central Enquiry Point Information Centre Medicines and Healthcare products Regulatory Agency Tel: 020 7084 2000

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----- Original Message -----
From: fiddaman
To: MHRA Information Centre

Sent: Tuesday, January 01, 2008 5:10 PM

Subject: Re: Dear Sirs

Thank you for pointing me to the correct statement. However, you have still failed to answer whether or not this is still the MHRA's position on the subject of addiction/dependency.

Is it?

Regards

Bob Fiddaman

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----- Original Message -----
From: MHRA Information Centre
To: fiddaman

Sent: Thursday, January 03, 2008 10:40 AM

Subject: RE: Dear Sirs

Dear Bob Fiddaman,

Thank you for your recent enquiry to the MHRA. We can confirm that this is the latest MHRA position on the subject of addiction/dependency.

Please contact us again if you need further assistance with this, or any other queries.

Kind Regards,

Central Enquiry PointInformation CentreMedicines and Healthcare products Regulatory AgencyTel: 020 7084 2000

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So there you have it ladies and gentlemen. The MHRA still stand by a report made some years ago, a report made without raw data being analysed.

You will notice that they... or probably their legal team will not answer yes or no as yes and no are definitive answers.

Now let me draw your attention to the following document on GlaxoSmithKline's webpage.

GSK European Promotion of Medicines Code of Practice 2nd Edition 2007.

Page 6: (Clause 4 - 4.10) "It must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency."


Unless of course you work for the MHRA!


Over to you Kent