Dr Healy and members of the MHRA met on 26 June 2009, the meetings purpose was to “discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants”. The MHRA, Dr David Healy meetings minutes can be downloaded here.
Following the MHRAs receipt of and the documents eventual publication on the internet, it was found to include the statement that “Venlafaxine in doses up to 150 mg is an SSRI.”. Clarification of venlafxines’ SSRI v SNRI classification was sought by way of a Freedom of Information (FoI) question and request sent to Simon Gregor, the MHRAs Director of Communications.
The FoI request for clarification was made because of concerns that the Defining Issue of the Seroxat Group Litigation Order No: 68, lodged at the High Courts by the Litigations Lead Solicitors Hugh James -
“Does Seroxat have a capacity to cause asverse effects consequent upon or following discontinuance (withdrawl) such as prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from taking Seroxat to a greater extent than all other Selective Serotonin Re-uptake Inhibitors (SSRIs)”is quite clear in it’s specification that it has to be proven that the discontinuation (withdrawal) and remaining free from Seroxat is worse and more difficult than any other “SSRI” in the drug class.
.…….. NB - spelling errors as per original document.
HM Courts Service: Seroxat Group Litigation Order no: 68.
With a certain amount of knowledge and the suspicion that the MHRA were not mandated to receive or facilitate a patient treatment protocol -- which would more likely fall under the sphere of influence of the National Institute for Clinical Excellence (NICE) -- an additional questions were asked to clarify if the MHRA were in a position, or intending, to authorise the Dr David Healy “Halting SSRIs” document as an official withdrawal protocol.
According the emailed reply (copy below) with regard the MHRA’s ability to facilitate utilising the Dr David Healy “Halting SSRIs” document the MHRA spokesperson states -
“As you are aware it is not within our remit to endorse guidelines for the management of patients.”With regard clarification of the venlafaxine SSRI v SNRI classification, the MHRA don’t appear to hold relatively basic information concerning the drugs dose related action on noradrenalin and serotonin –
although they had approved the “Summery of Product Characteristics, which is produced by the marketing authorisation holder” which presumably would have included the products name and category i.e. SSRI, SNRI, significance as such and dosage information.
The MHRA spokesperson did however quote from the official NICE “Guidance” on “treatment of depression” which states ‘At standard dose of 75 mg, venlafaxine is an SSRI. At doses of 150 mg/day and above it also inhibits the reuptake of noradrenaline and, to a lesser extent dopamine’ – adding the endorsement that they “have no reason to doubt” this.
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Published with permission of the recipient, original document here.
It would appear that the official view of the UK Governments Medicines and Healthcare products Regulatory Agency (MHRA), Department of Health (DH), National Health Service (NHS) and National Institute for Clinical Excellence (NICE) is that venlafaxine (Wyeth, Efexor UK, Effexor USA) , at standard doses up to 150 mg, is classified as an SSRI.