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Garland, 2016 Update on the Use of SSRIs and SNRIs with Children and Adolescents in Clinical Practice.

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Altostrata   
Altostrata

Evidence for efficacy and safety in children is even more scarce than that in adults.

 

J Can Acad Child Adolesc Psychiatry. 2016 Winter;25(1):4-10. Epub 2016 Feb 1.

Update on the Use of SSRIs and SNRIs with Children and Adolescents in Clinical Practice.
Jane Garland E1, Kutcher S2, Virani A3, Elbe D4.
 
Abstract at http://www.ncbi.nlm.nih.gov/pubmed/27047551Full text at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4791100/
 
From the paper:
 
Background
As concerns about the use of antidepressants in children and adolescents arose in 2003, there was uncertainty about the safety and efficacy of these medications in this patient population. To help clinicians better understand the available evidence, we published a position paper in 2008 on behalf of CACAP. This position statement provides an update to our earlier position paper on the use of Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) in the treatment of Major Depressive Disorder (MDD) and Anxiety Disorders in children and adolescents. It is not intended to be a comprehensive review of the treatment options for anxiety and depression in children and adolescents. We will endeavor to update this position paper as new relevant information pertinent to the clinical use of these medications in this patient population becomes available. In addition to a review of new trials published from up to mid-2015, the following update was supported by a requested independent systematic review of research on safety and efficacy by the Canadian Agency for Drugs and Technology in Health (CADTH, 2015).
....

Conclusion
SSRIs and SNRIs for children and adolescents with MDD and/or anxiety disorders are neither a panacea nor contra-indicated. The best available evidence suggests that fluoxetine may be the medication of choice for use in both MDD and anxiety disorders. In most situations given limitations and uncertainty in the available data, SNRIs are not recommended as first line treatments.
When properly applied and monitored, medication treatment may be of substantial benefit to some individuals. Initiation of SSRI medications should be reserved for those who are moderately to severely depressed and requires careful monitoring. Both patients and caregivers need to be properly informed about both the potential for benefits and risks. We strongly suggest that medications should not be prescribed outside of a comprehensive treatment approach that includes supportive, problem-focused psychotherapeutic interventions, assessment and monitoring of suicide risk and education about these disorders and their treatment.

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nz11   
nz11

The best available evidence suggests that fluoxetine may be the medication of choice for use in both MDD and anxiety disorders.

Personally i find such conclusions horrifying.

 

Four days prior to this the telegraph had published ...

http://www.telegraph.co.uk/science/2016/03/14/antidepressants-can-raise-the-risk-of-suicide-biggest-ever-revie/

 

Commenting on the findings of the review Professor Gotzsche added, "It is absolutely horrendous that they have such disregard for human lives."

 

What about Jake...

http://www.dailymail.co.uk/health/article-3503456/Weeks-Prozac-Jake-14-took-life-aren-t-parents-warned-suicide-risk-children-anti-depressants.html

 

Wow look what i saw in the reference list in the Garland et al article...

These authors have referenced Keller.....(how come in 2016 this article is being referenced...?!?!?!)

  • Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, McCafferty JP. Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry. 2001;40(7):762–772. [PubMed]

 

I wonder what they referenced from Keller ??

 

'Some suffer from design, implementation or analytical problems that make results difficult to interpret. Some studies may have failed to demonstrate significant efficacy using primary outcomes but when secondary outcomes are analyzed they suggest significant differentiation from placebo or tricyclic comparators' (Keller et al., 2001)

 

hmmm ok so translated this means if supportive evidence cant be found for primary outcomes, that is your study is a negative study, then just change the rules and go data dredging, consult with the ghostwriters, misconduct experts and spin doctors and do what we did in the 2001 study in order to turn a negative study into a positive one... ie

Use of idiosyncratic coding system

Failure to transcribe all and adverse events from clinical record to an adverse event database

Filtering data on adverse events through statistical techniques

Restriction of reporting to events that occurred above a given frequency in any one group, Coding event under different headings for different patients (dilation),

Grouping of adverse events,

 Insufficient consideration of severity,

Coding of relatedness to studied medication

Masking effects of concommit drugs,

Ignoring effects of drug withdrawal.

 

Here is an linked excerpt from the Garland et al study...this is in stark contrast to black box warning and all the information available today...

 

Best available data from controlled trials and health record databases alike show that SSRI treatment significantly decreases suicidal ideation and suicide attempts in young people (Cheung et al., 2006;March et al., 2004b; Mosholder, 2004; Kutcher & Gardner, 2008). Population studies demonstrate an inverse correlation between antidepressant use and youth suicide (Olfson, Shaffer, Marcus & Greenberg, 2003; Gibbons, Hur, Bhaumik & Mann, 2006). In addition, post-mortem studies have not demonstrated a relationship between SSRI use and youth suicide (Leon et al., 2006; Isacsson, Holmgren, & Ahlner, 2005). Given all available data to date it appears far more likely that SSRI use decreases suicide rates rather than increases them. At the individual patient level however, SSRI use can be associated with emotional/behavioral side effects that require appropriate clinical management. There is limited information comparing SNRIs to SSRIs. In one trial, there was no statistically significant difference in suicidality with venlafaxine compared to SSRIs, although both cardiovascular and dermatological adverse effect rates were higher than with SSRIs (Brent et al., 2008). There was an indicator of higher suicide-related behaviours with venlafaxine compared to SSRIs in a meta-analysis of trial data (Hammad et al., 2006).

 

 

In addition, post-mortem studies have not demonstrated a relationship between SSRI use and youth suicide (Leon et al.,

Here is the conclusion from this study...

CONCLUSIONS:

The detection of antidepressants at autopsy was quite rare in youth suicides in New York City from 1999 to 2002.

 

Here is the thing what if they stopped taking their drug and it left the system but the system is now a profoundly impaired-inwithdrawal- one ..would it not be more accurate to consider who had ever been exposed to an ad and when rather than who had or did not have ad in the body?

Like Mr Keller they may not considering withdrawal ...

 

When i look at that Mosholder link i find a disclaimer in respect of prozac being

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

 

Is Andy just going on whatever the company tells him then?  Wouldnt be a first ...

 

In a 1993 FDA approval review of Risperdal, Andrew Mosholder, one of the agencies reviewers, notes that:

 

 

“The sponsor reports no instance of risperidone abuse or dependence. Withdrawal phenomena were not formally assessed after patients discontinued risperidone. Several patients committed suicide within one month of discontinuing risperidone, however, it does not seem reasonable to attribute this to withdrawal, given the absence of other indications of a risperidone withdrawal syndrome and the fact that schizophrenia is known to be a risk factor for suicide”.

Healy commented on this statement from Mosholder saying ."[it] is a totally unwarranted assumption.  There is a compelling case antipsychotics cause dependence and withdrawal"  "[Risperdal] data do not include suicides and suicidal acts that might have been triggered by withdrawal. "

 

Do you think Mosholder is wrong in respect of ads as well ?

I'm too lazy to look into it but whats the bet that the Mosholder and Cheung links in 2004 and 2006 (claiming ads decrease suicide ) came out just prior to the FDA hearings in respect of  ads causing suicide... covert  pharma attempts to protect their golden goose.

.

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