FDA antidepressant advisory for ADULTS and SUICIDALITY.

Statement by Nuria O'Mahony
Holistic Action Group (founder)


After losing my husband to antidepressant induced suicide in 2003 and obtaining an open verdict during the inquest into his death. I am pleased to welcome the warning released by the FDA on the 30th of June 2005 including ALL ADULTS on their antidepressant warning. I have been campaigning for this kind of warning to be released in Ireland for the last 18 months. After many correspondences with the Irish Medicines Board, The Minister for Health Mary Harney and his predecesor Micheál Martin, Oposition Members, Independent Senator and including the EMEA (the medicines european agency) and European Commission to be IGNORED and no action has been taken. I regret that many people's lives could have been saved if only the regulatory bodies listened to the CONSUMERS and it was a bit more critical of the data provided (or not) by the pharmaceuticals and scrutinised this data on the best interest of the patient, not the pharmaceuticals.

The experience of consumers must be CENTRAL to a modern system for the licensing and regulation of prescription drugs and that reports of adverse reactions by consumers must be given at least as equal weight by the regulator as the clinical trials data supplied by pharmaceutical companies. The clinical trials data cannot be called scientific if it is not ALL available for independent scrutiny to support the findings. This is in the best interest of CONSUMERS.

Today I am demanding immediate action to remedy this misconceived, chaotic situation surrounding antidepressants today in Ireland, specially the family of the SSRIs. The recent EMEA warning regarding paroxetine only goes up to the age of 30 and it does not go as far as their American counterparts have gone....to ALL ADULTS suggesting the POSSIBILITY of an INCREASED RISK FOR SUICIDAL BEHAVIOUR in adults treated with antidepressant medications.This kind of warning is necessary to save lives. There are not similar warnings for the rest of the SSRIs regarding the adult population in Ireland.

The longer it takes for such a warning to be issued in Ireland the longer the Irish people are going to continue to suffer with PREVENTABLE drug induced problems that could end up in suicide as the case of my husband. This warning is DETRIMENTAL for Doctors to realise that following the National Institute of Clinical Excellence (NICE) guidelines in the treatment of depression is in the best interest of the patient and it would spare upto 67% of depressed people (on antidepressants) suffering with MILD DEPRESSION to go on these tablets unnecessarily causing more harm than good. This is in the best interest of the mildly depressed people of Ireland and it is confirmed in the NICE guidelines by not recommending antidepressants to be prescribed to MILDLY DEPRESSED patients.

This suicide and aggression adverse effect can happen to anyone who takes these drugs regardless of the reason for the prescription. For 15 yrs the pharmaceutical companies have been blaming the patients and the "disease" for the violence and suicides. Doctors and family members MUST be aware that the drug itself can make the patients become aggresive and suicidal.

I call for the appropriate necessary warning to be released in Ireland as soon as possible to save lives.


Nuria O'Mahony
Holistic Action Group (founder)

Warning: Nobody should stop antidepressant medication suddenly without medical supervision as it can cause severe withdraw symptoms, causing HARM. Consult your doctor.

Notes:

Paroxetine PIS document:

FDA alert = CLOSELY WATCH ANYONE TAKING ANTIDEPRESSANTS, ESPECIALLY EARLY IN TREATMENT OR WHEN THE DOSE IS CHANGED. PATIENTS WHO BECOME IRRITABLE OR ANXIOUS, OR HAVE NEW OR INCREASED THOUGHTS OF SUICIDE OR OTHER CHANGES IN MOOD OR BEHAVIOR SHOULD BE EVALUATED BY THEIR HEALTHCARE PROFESSIONAL RIGHT AWAY.

Paroxetine HCP document:

Recommendations = ADULTS being treated with antidepressants should be observed similarly (to pediatric patients-see FDA alert & pediatric reccommendations) for clinical worsening and suicidality, especially during the INITIAL few months of a course of therapy, or at times of dose changes, either increases or decreases. Consideration should be given to changing the therapeutic regimen, INCLUDING possibly DISCONTINUING the MEDICATION, ESPECIALLY IF THESE SYMPTOMS ARE SEVERE, ABRUPT IN ONSET, OR WERE NOT PART OF THE PATIENT'S PRESENTING SYMPTOMS.

Latest patient leaflet SSRIs document:

Warnings-Clinical Worsening and Suicide Risk = Page 2 Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal IMPULSES has not been established, there is CONCERN that such symptoms may REPRESENT PRECURSORS to EMERGING SUICIDALITY. Families and Caregivers of ADULTS being treated for depression SHOULD BE SIMILARLY ADVISED (see pediatric advice).

Precautions = Prescribers should INFORM patients, their FAMILIES and their CAREGIVERS about the BENEFITS and RISKS associated with treatment with SSRIs and SHOULD counsel them in its appropriate use See advice under Precautions-Clinical Worsening and Suicide Risk.