From: Fawbert, Stephen [Stephen.Fawbert@mhra.gsi.gov.uk]

Sent: 04 July 2006 13:48

To: ds010z5045@blueyonder.co.uk

Subject: Our ref: FOI 06-191

Dear Mr Scott

Thank you for your email of 6 June about an increased risk of suicide in young adults prescribed the antidepressant medicine Seroxat.  As this matter falls within my division it has been passed to me for reply.

You have asked why there was a two year gap between communications made in 2004 and 2006 on this matter.  The reason for this is that different evidence came to light in the intervening period, and not all the facts known in 2006 were known in 2004.  However, we do not consider the communications made in 2004 and 2006 to be contradictory and I hope it will be helpful if I set out some of the background below.

As you are aware, the Committee on Safety of Medicines Expert Working Group on the safety of SSRIs conducted a comprehensive review of the safety of SSRIs focusing on the key areas of concern: suicidal behaviour and the withdrawal reactions. From the beginning of the review the Expert Working Group and MHRA were keen to ensure that the workings of the Group were entirely transparent and the basis for the recommendations of the Group were clearly set out.

The conclusions were communicated to UK health professionals on 6 December 2004 and both the final report of the Group and the letter to health professionals were made available on the MHRA website. A questions and answers document for patients was also published on the website, a statement was laid in Parliament, and a press conference was held to inform the national press of the findings of the Group. 

The Expert Working Group concluded that the balance of risks and benefits of most SSRIs for the treatment of depression in children and adolescents was negative and they should not be used in this population. The Expert Working Group concluded that the balance of risks and benefits of all SSRIs in adults remains positive; however prescribers and patients should be more aware of the side effect profile of these medicines and the need for close monitoring of patients.  With regard to the risk of suicidal behaviour in adults the key findings of the Expert Working Group included that based on the available clinical trial data, both published and unpublished, a modest increase in the risk of suicidal thoughts and self-harm for SSRIs compared with placebo cannot be ruled out.  Furthermore, given that individuals mature at different rates and young adults are at a higher background risk of suicidal behaviour than older adults, it was thought that as a precautionary measure young adults treated with SSRIs should be particularly closely monitored.

In parallel to the work of the Expert Working Group, there was an ongoing Europe-wide review of the risks and benefits of Seroxat undertaken by the then Committee on Proprietary Medicinal Products (CPMP).  This review also concluded that no strong evidence had been found to support an increased risk of suicidal behaviour in young adults aged 18-29 years.  The CPMP, however, recommended that patients at high baseline risk of suicidal behaviour should be closely monitored during treatment with paroxetine. These include patients with a known history of suicidal behaviour or thoughts prior to starting treatment, and young adults as a patient group. In April 2004, a summary of the opinion of the CPMP referring to the need for monitoring young adults during paroxetine treatment was released on the EMEA and MHRA websites. This message was reiterated in the October 2004 edition of the drug safety bulletin Current Problems in Pharmacovigilance which is sent to all doctors and pharmacists in the UK.

In May 2006 we received data from new analyses of Seroxat clinical trials which suggest that adults, particularly young adults with depressive illness, may be at an increased risk of suicidal behaviour when treated with Seroxat.  Whilst these new analyses highlight the importance of monitoring they do not alter the prescribing advice for SSRIs issued in December 2004.  Healthcare professionals have been reminded of this advice via a letter from the Chairman of the CHM and information has been posted on the MHRA website including a Question and Answer document for patients.

I hope this reply reassures you that we take the issue of SSRIs and suicidal behaviour very seriously and will continue to monitor any new evidence that is published.  We will always make sure that we communicate any important new safety information effectively and promptly once it becomes available.

Yours sincerely

Mr Stephen Fawbert
Freedom of Information Coordinator
Vigilance and Risk Management of Medicines Division

Stephen Fawbert
Information for Public Health Group, VRMM
Medicines and Healthcare products Regulatory Agency (MHRA)
Market Towers 14-110
1, Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 2788

This email and any files transmitted with it are confidential. If you are not the intended recipient, any reading, printing, storage, disclosure, copying or any other action taken in respect of this email is prohibited and may be unlawful.

If you are not the intended recipient, please notify the sender immediately by using the reply function and then permanently delete what you have received.Incoming and outgoing email messages are routinely monitored for compliance with the Department of Healths policy on the use of electronic communications.

For more information on the Department of Healths email policy, click http;//www.doh.gov.uk/emaildisclaimer.htm

The original of this email was scanned for viruses by Government Secure Intranet (GSi) virus scanning service supplied exclusively by Cable & Wireless in partnership with MessageLabs.
On leaving the GSI this email was certified virus free.
The MessageLabs Anti Virus Service is the first managed service to achieve the CSIA Claims Tested Mark (CCTM Certificate Number 2006/04/0007), the UK Government quality mark initiative for information security products and services. For more information about this please visit www.cctmark.gov.uk