Seroxat Archives - Dr. Julie Williams, MHRA, June 15, 2006

----- Original Message -----
From: Sodipe, Atinuke
To: fiddaman64
Sent: Thursday, June 15, 2006 12:16 PM
Subject: TO82333


Thank you for your correspondence of 16 March 2006 about the antidepressant, paroxetine (brand name Seroxat).

As you are aware, the conclusions and key findings of the Committee on Safety of Medicines Expert Working Group on the safety of SSRIs were communicated to health professionals on 6 December 2004. In reaching its conclusions, the CSM’s Expert Working Group considered a large body of evidence, including information from clinical trials (including trials involving over 13,000 individuals treated with paroxetine), epidemiological studies, evidence from experts and spontaneous reporting data including reports of patients’ experiences. The Group also considered feedback from meetings between members of the Expert Working Group, officials from the Medicines and Healthcare products Regulatory Agency (MHRA) and patient support groups including the Seroxat Users Group. The key findings of the Expert Working Group in relation to suicidal behaviour, included that based on the available clinical trial data, both published and unpublished, a modest increase in the risk of suicidal thoughts and self-harm for SSRIs compared with placebo cannot be ruled out.

The available clinical trials with Seroxat (paroxetine) were evaluated rigorously during the Expert Working Group’s review. However, I have asked Departmental officials to carefully consider the concerns you have highlighted and Dr Breggin’s report including his claims that GSK has suppressed data, which clearly show paroxetine treatment, may increase the risk of suicidal behaviour in adults. If the claims are substantiated then of course appropriate action will be taken

I wish to assure you that the concerns you have raised about any prior knowledge that Professor Breckenridge and Dr Hudson may have had about the Seroxat clinical trials have been raised with officials and I am confident that neither Professor Breckenridge nor Dr Hudson had prior knowledge of the data discussed in Dr Breggin’s report.

The MHRA continues to investigate whether there was any delay on the part of Glaxo SmithKline in communicating the clinical trial data in the paediatric population to the Agency. The investigation is being treated as a high priority by the MHRA and substantial additional resources have been applied by the Agency with a view to expediting its progress.

The safety of Seroxat remains under close constant scrutiny by the MHRA. Recently on the advice of the independent scientific advisory body, the Commission on Human Medicines (CHM), communications have been issued to doctors about the safety of paroxetine during pregnancy, following studies which suggest that birth defects may be more common in babies whose mothers took paroxetine early in their pregnancy. The Seroxat product information has been updated to reflect these new data.

You also mention the recent tragic events relating to the young men who suffered serious unexpected adverse drug reactions during the healthy volunteer trial conducted by Parexel at Northwick Park. The immediate priority was to suspend the trial to ensure that no further individuals were harmed. The MHRA has now begun an exhaustive investigation to determine the cause and to ensure that all appropriate action is taken.

Dr. Julie Williams
Vigilance and Risk Management of Medicines (VRMM)
MHRA