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Selective serotonin reuptake inhibitors (SSRIs) and suicide in adults: meta-analysis of drug company data from placebo controlled, randomised controlled trials submitted to the MHRA's safety review

BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7488.385 (Published 17 February 2005) Cite this as: BMJ 2005;330:385

Rapid Response:

Response to Professor David Healy's correspondence (18 February 2005)

Dear Editor,

Professor Healy (18 February 2005) raises concerns about two of the
numbers used in our meta-analysis. As we highlighted in our paper, the
data were drawn from the report of the Medicine and Healthcare products
Regulatory Agency’s (MHRA) review of the safety of SSRIs (1). We can
confirm that the Expert Working Group’s report did, in fact, include one
suicide amongst placebo treated patients in placebo-controlled trials of
citalopram for depression (see Table 7.16 on page 84). Likewise data on
paroxetine are available in the report (see section 7.2.1 on page 74) and
were included in our meta-analyses. Three of the four suicides in the
placebo-controlled trials of paroxetine were reported as having occurred
in the post-treatment period and the one paroxetine suicide occurred on-
treatment.

We have communicated with the MHRA concerning Professor Healy’s
concern with the paroxetine suicide data. In further consultation with GSK
(the license holder for paroxetine) the MHRA confirm that the four
suicides in adult placebo-controlled randomised trials of paroxetine were
distributed as described above (personal communication: MHRA).

Department of Social Medicine, University of Bristol, Bristol BS8 2PR

David Gunnell

professor of epidemiology

Wolfson Institute of Preventive Medicine, Queen Mary, University of
London; London EC1M 6BQ

Julia Saperia

research assistant

Deborah Ashby

professor of medical statistics

1. Report of the CSM Expert Working Group on the safety of selective
serotonin reuptake inhibitors. 2004.
http://www.mhra.gov.uk/news/2004/SSRIfinal.pdf

Competing interests:
DG and DA were members of the MHRA’s expert working group on the safety of SSRIs. We acted as independent advisors, receiving travel expenses and a small fee for meeting attendance and reading materials in preparation for the meeting. DA has spoken on the methodology of adverse drugs reactions in HIV at a scientific meeting attended by several pharmaceutical companies, and sponsored by GSK. An honorarium was paid to her department. JS has no competing interests.

Competing interests: No competing interests

23 March 2005
David J Gunnell
Professor of Epidemiology
Julia Saperia, Deborah Ashby
Department of Social Medicine, University of Bristol. BS8 2PR