Serotonin - GSK & The MHRA

Here is my latest FOI request to the MHRA:

Tuesday 2nd Jan 2007

FOI Request

Dear Sir/Madam,

Could you please provide me with answers to the following:

On the Seroxat Patient Information Leaflet (PIL) it states;


'Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain'

I would like to bring to your attention the statement in blue, 'People who are depressed or anxious have lower levels of serotonin than others.'

In a recent communication with your MHRA Vigilance and Risk Management of Medicines (VRMM) Division, I was told,

"...we are not aware of an internationally agreed "proper chemical balance of serotonin in the brain"

Therefore, this begs the question how Glaxo SmithKline can issue such a statement on their PIL for Seroxat?

1. Did GSK provide the MHRA background documents giving details about the imbalance of serotonin in the brain?
Please answer Yes or No

2. Did GSK provide the MHRA documents with figures for the effect the drug had in changing the imbalanced state?
Please answer Yes or No

3. Please forward me documents that GSK supplied the MHRA during the application procedure for Seroxat that relate to the 'correcting effect' regarding people with lower levels of serotonin.

Meantime, I look forward to your reply.

Mr Robert Fiddaman

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I will, of course, upload answers from the MHRA to this blog when I recieve them


Bob