The MHRA has concluded its investigation into GlaxoSmithKline (GSK) and its antidepressant drug, Seroxat. A press release and accompanying documents are available below.
Documents released under the Freedom of Information Act
The documents being published today include three sets of papers dating from May and June 2003, and consist of:
- the clinical trial data analyses provided by GSK, as referred to in Section 1 of the report being published today, 'MHRA Investigation into Glaxosmithkline/ Seroxat' (para 9ff); and
- the MHRA’s assessment reports on those analyses, as provided to the Committee on Safety of Medicines and sub-group on SSRIs (Selective Serotonin Reuptake Inhibitors).
They are being released under provisions in the Freedom of Information Act 2000. Any redactions in the documents relate to names of individuals, and are withheld under either exemption 38 or 40 of the Freedom of Information Act 2000.
Aside from these redactions of names, the MHRA consider that, in line with the provisions of the FOI Act, the public interest in disclosing the information contained in the documents outweighs the public interest in maintaining its confidentiality.
- 11. Transcript of a meeting with patient representatives on 29 April 2008 (207Kb)
- 10. MHRA response to letter from GSK Chief Medical Officer - 16 April 2008 (320Kb)
- 09. Letter from GSK Chief Medical Officer to MHRA - 18 March 2008 (1183Kb)
- 05. Summary of regulatory action (14Kb)
- 08. Committee on Safety of Medicines: Expert Working Group assessment report - 16 June 2003 (2805Kb)
- 06. Committee on Safety of Medicines assessment report - 22 May 2003 (4167Kb)
- 07. Committee on Safety of Medicines assessment report - 4 June 2003 (897Kb)
- 01. Press release: GSK investigation concludes (57Kb)
- 02. MHRA Investigation into Glaxosmithkline/ Seroxat (69Kb)
- 04. GSK Seroxat - letter to trade associations (334Kb)
- 03. GSK Seroxat - letter to GSK (76Kb)