Skip to main content Accessibility help
×
Home

Response from Pfizer

Published online by Cambridge University Press:  02 January 2018

N. Power
Affiliation:
Mental Health, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS, UK
K. Lloyd
Affiliation:
Pfizer Ltd
Rights & Permissions[Opens in a new window]

Abstract

Image of the first page of this article
Type
Columns
Copyright
Copyright © 2002 The Royal College of Psychiatrists 

The possible association between SSRIs and suicidal behaviour has been the subject of intense discussion throughout the 1990s, following the publication of case reports of suicidal behaviour suspected to be associated with fluoxetine.

Healy states that three of five suicide attempts characterised as placebo suicide attempts in the sertraline trial programme reported by Khan et al occurred during the washout period rather than while on placebo. All of the five suicide attempts to which he refers occurred while patients were on placebo, three of which occurred during the washout period. Healy similarly states that three of six suicide attempts and two completed suicides also occurred during washout rather than while on placebo in the paroxetine trial programme. Pfizer does not have access to data regarding other companies' products and cannot therefore comment whether this is accurate or not. Healy concludes that taking this information into account and reanalysing the data, there is a statistically significant general increase in the risk of suicidal acts in patients taking novel antidepressants when compared with placebo. However, since this is based on inaccurate information, at least as regards sertraline, it is not a justifiable conclusion.

Pfizer has submitted information specific to when deaths occurred to the Medicines Control Agency (MCA) as well as other regulatory bodies, in compliance with worldwide regulatory requirements.

As with all medicines, the safety of the SSRIs is continually monitored by the MCA and the independent expert advisory body, the Committee on Safety of Medicines (CSM). Since 1992 a number of epidemiological studies and analyses of clinical trial data have failed to establish a causal association between the SSRIs and suicidal behaviour, and the CSM has reviewed this issue on a number of occasions. The most recent review, conducted in 2001 and discussed at the CSM on 12 December 2001, concluded that ‘the current evidence is insufficient to confirm a causal association between SSRIs and suicidal behaviour’ (Commons Hansard Written Answers, 2002) and advised that the issue should be kept under review.

The product information and the British National Formulary warn that patients should be closely monitored for suicidal impulses, and an article emphasising this advice was also published in the MCA/CSM drug safety bulletin in September 2000.

Footnotes

EDITED BY MATTHEW HOTOPF

References

Commons Hansard Written Answers (2002) 4 February, Vol. 379, part no. 94, column 780WGoogle Scholar
MCA/CSM (2000) Selective serotonin reuptake inhibitors (SSRIs). Current Problems in Pharmacovigilence, 26, 1112.Google Scholar
Submit a response

eLetters

No eLetters have been published for this article.

Full text views

Full text views reflects PDF downloads, PDFs sent to Google Drive, Dropbox and Kindle and HTML full text views.

Total number of HTML views: 31
Total number of PDF views: 51 *
View data table for this chart

* Views captured on Cambridge Core between 02nd January 2018 - 22nd January 2021. This data will be updated every 24 hours.

Access
Hostname: page-component-76cb886bbf-fv2z2 Total loading time: 2.856 Render date: 2021-01-22T05:36:31.681Z Query parameters: { "hasAccess": "1", "openAccess": "0", "isLogged": "0", "lang": "en" } Feature Flags: { "shouldUseShareProductTool": true, "shouldUseHypothesis": true, "isUnsiloEnabled": true, "metricsAbstractViews": false, "figures": false, "newCiteModal": false }

Send article to Kindle

To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Response from Pfizer
Available formats
×

Send article to Dropbox

To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

Response from Pfizer
Available formats
×

Send article to Google Drive

To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

Response from Pfizer
Available formats
×
×

Reply to: Submit a response


Your details


Conflicting interests

Do you have any conflicting interests? *