WARNINGS of the dangers of suicidal thoughts and behaviour are to be included in the packages of anti-depressants. Warnings will be carried in the patient information leaflet in the packets from October this year. The direction was issued yesterday (Tues
WARNINGS of the dangers of suicidal thoughts and behaviour are to be included in the packages of anti-depressants. Warnings will be carried in the patient information leaflet in the packets from October this year.
The direction was issued yesterday (Tuesday) by the Government's Medicines and Healthcare Products Regulatory Agency. (MHRA)
A notice has been sent to drug manufacturers. It mentions a review by the Food and Drugs Agency in America, which looked at bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline and venlaxfaxine.
The review found no risk of higher sucidality in the general population but said younger people were at higher risk and that there were no differences in the risk between antidepressant classes.
A statement released by the MHRA says that the wording of warnings has been agreed by the EU as has the time table for implementation.
The agreed wording reads:
"Thoughts of suicide and worsening of your depression or anxiety disorder. If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
If you have previously had thoughts about killing or harming yourself.
If you are a young adult.
Information from clinical trials has shown an increased risk of suicidal behaviour in young adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse or if they are worried about changes in your behaviour."
The news was greeted as a victory by anti-drugs campaigner, Janice Simmons, a grandmother from Great Stukeley in Huntingdon.
Mrs Simmons told The Hunts Post on Tuesday: "I've won. This is the result of eight years' work. Warnings of suicidal thoughts and behaviour will now be carried on all anti-depressants."
Mrs Simmons, 57, began her campaign after she discovered that her second husband, John had been prescribed Seroxat years before she met him and since become addicted to anti-depressants. Her help-group - the Seroxat User Group - has had tens of thousands of hits on its website. Mrs Simmons has gathered information from across the world. She has begun a dossier of case histories of tragic effects on people who have been prescribed anti-depressants.
and this year had a meeting with the Prime Minister, Gordon Brown to discuss the problem. However, she has always conceded that the drugs can help some people.
One of the issues Mrs Simmons discussed with Gordon Brown was the length of time (four years) that the MHRA has taken to investigate allegations against the manufacturer of Seroxat, GlaxoSmithKline.
It is alleged that the drugs giant withheld information that Seroxat could cause suicide in under 18s. The allegations have always been denied and GSK has said that Seroxat was never licensed for children.
For a full report see www.huntspost24.co.uk See also www.mrha.gov.uk and www.seroxatusergroup.org.uk