ALL antidepressants to carry suicide warning in UK

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Implementation of warnings on suicidal thoughts and behaviour in

antidepressants

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Variations to licences

Companies that hold authorisations for antidepressant products will

shortly be receiving letters requesting Type II variations to update

the warnings on suicidal thoughts and behaviour in line with European

agreements. Authorisation holders should submit the applications no

later than 3 March 2008.

Background

The Pharmacovigilance Working Party (PhVWP) has considered the

results of a meta-analysis of adult clinical trial data for SSRIs and

other antidepressants recently completed by the FDA. The drugs

included in the FDA review were bupropion, citalopram, duloxetine,

escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone,

paroxetine, sertraline and venlafaxine. The PhVWP considered the

review performed by the FDA was of high quality and although it did

not provide evidence to suggest that the use of SSRIs and related

depressants leads to an increased risk of suicidality in the general

adult population, it found a clear age effect with younger age groups

having higher odds ratio estimates than older age groups. The results

of the review found no marked differences in terms of risk of

suicidal thoughts/behaviour across the different antidepressant

classes. In the light of the results of the FDA review the PhVWP

agreed that the `EU core SPC for SSRIs and related substances' of

October 2005 should be modified with regard to suicidality and should

now be extended to cover all antidepressants. In particular, the

wording should be updated with respect to the increased risk to young

adults and the need for close monitoring of patients, and it will be

applicable to all antidepressants, not only SSRIs.

The wording has been agreed at an EU level in consultation with MA

holders for brand leader products and industry associations. The

timetable for implementation has also been agreed at European level

to ensure that healthcare professionals, patients and their carers

receive this important safety information as soon as possible.

Amendments required

The agreed wording can be found as a download document at the end of

this page.

Further information

Further information on the scientific basis of this regulatory action

and questions and answers on the procedure for updating SPCs and PLs

is available for download at the end of this page.

For further advice on the submission of your variation please contact

Ms Anne Ambrose (Tel: 020 7084 2186) or Ms Saadia Sharief (Tel: 020

7084 2951)

Download documents:

Implementation of warnings on suicidal thoughts and behaviour in

antidepressants - Public assessment report

Implementation of warnings on suicidal thoughts and behaviour in

antidepressants - wording for all antidepressants

Implementation of warnings on suicidal thoughts and behaviour in

antidepressants - Questions and Answers