Implementation of warnings on suicidal thoughts and behaviour with antidepressants by MHRA

...but this does not apply to anyone over the age of 25


The MHRA has notified companies that hold authorisations for antidepressant products that they will shortly be receiving letters requesting Type II variations to update the warnings on suicidal thoughts and behaviour in line with European agreements. The Pharmacovigilance Working Party (PhVWP) had considered the results of a meta-analysis of adult clinical trial data for SSRIs and other antidepressants recently completed by the FDA. It 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 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.

Wording on ALL antidepressants PDF


So if you take antidepressants and are over the age of 25 the MHRA think you are not at risk!

I wonder if this release has anything to do with the current MHRA investigation into GlaxoSmithKline regarding them witholding clinical trial data?

More than likely will be their statement if they find GSK guilty.

I can just hear the MHRA now

'We have agreed to change the wording on the patient information leaflets on ALL antidepressants'

This is JUST NOT GOOD ENOUGH!

Forgive me if I don't break open the Champagne. A step in the right direction it is but there is much more work to be done - this is merely papering over the cracks and is over one year behind what the FDA already did in America regarding black box warnings.

Don't take the plaudits too serious yet Mr Woods - there are still many of us over the age of 25 who disagree with this pathetic 'age ruling'