Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0100/0546
Facsimile 0171- 273 0548	.
	our ref : 37-KHJ-0100

 

Dear Dr Healy,

Thank you for your letter and enclosures of 4 November relating to Prozac and suicide. The points you raise have been noted with interest and I have the following comments.

You make a suggestion that more information on adverse reactions to investigational products could be obtained by having a checklist of expected events and reactions that each patient is asked to fill in or respond to. This technique is used in some. clinical trials already and may provide additional information as you suggest. New methods are being researched to try to identify safety signals from large databases of safety data. The MCA has been involved in some of this research.

It is important to emphasise that only a relatively few patients are exposed to a medicine in clinical trials before it is marketed. This means that relatively rare adverse reactions to the product will not be detected in clinical trials. For this reason the UK introduced the Black Triangle Scheme to monitor the spontaneous reports from newly marketed products more intensively during the first few years or until a sufficiently large number of patients would have been exposed to it. Therefore, focussing on safety data from clinical trials in formulating an opinion of the safety of its potential to cause any one reaction may be difficult. Post-marketing safety data is vital to establish the safety profile of a new medicine.

One of the primary roles of the Medicines Control Agency is to ensure that prescribers and patients are adequately informed about their medicines to allow them to use it as safely and effectively as possible. Your letter raises the issue about the warnings currently given to prescribers on the risk of suicide in early treatment with Prozac and other antidepressants.

The Prozac Summary of Product Characteristics (SPC) currently contains the following statement:

'As improvement may not occur during the first two weeks of treatment, patients should be closely monitored during this period The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs.'

We have carried out an initial review of data collected via the Yellow Card Scheme. The number of reports of suicide, akathisia, aggression and related terms spontaneously reported via the scheme are shown in the table attached. It is important to note that a report of a suspected adverse reaction does not necessarily mean that it was caused by the drug. The numbers of reports in the attached table should be seen in the context of the huge usage of Prozac. Over 7,000 reports of suspected adverse drug reactions have been received in association with Prozac in the UK. It is also worth noting that media publicity surrounding a particular issue can stimulate the reporting of adverse drug reactions.

An analysis of onset times of reaction for these terms showed that the majority, although not all, of these reactions occurred within the first few weeks of treatment.

The issue of suicide associated with fluoxetine was first reviewed by the Committee on Safety of Medicines in 1990 and it was concluded that the available evidence did not support an increased risk of such problems with fluoxetine. We are continuing to keep this matter under close review.

If you are aware of any further information on this matter, we would be very pleased to receive it.

Yours sincerely

Dr Keith Jones

Director & Chief Executive

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Table of UK ADROIT reports of suicide, akathisia, aggression and related terms.

Term	Number of reports
Aggression	165
Agitation	315
Akathisia	25
Non-accidental overdose	9
Overdose NOS (not otherwise specified)	18
Parasuicide	1
Suicidal ideation	98
Suicide (accomplished)	44
Suicide attempt	54

 

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