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EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

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EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby anacleta » Tue Jun 11, 2019 1:23 am

https://rxisk.org/ema-acknowledges-pers ... ris-snris/
https://postssrisexualdysfunction.blogspot.com/
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby sylv » Tue Jun 11, 2019 5:39 am

That's a really great information. Despite some misunderstandings we owe big thanks to dr Healy. He had big role in this decision.

The next important step is FDA decision in regard to the same petition and gaining similar recognition for persistent Emotional Blunting after stopping SSRI antidepressants which frequently coexist with sexual dysfunction.
Last edited by sylv on Tue Jun 11, 2019 9:19 am, edited 1 time in total.
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby link11 » Tue Jun 11, 2019 6:59 am

sylv wrote:That's a really great information. Despite some misunderstandings We owe big thanks to dr Healy as He had big role in this decision.

The next important step is FDA decision in regard to the same petition and gaining similar recognition for persistent Emotional Blunting after stopping SSRI antidepressants which frequently coexist with sexual dysfunction.


I agree. I never got PSSD, just emotional blunting/anhedonia.
I was disappointed that they did not push for its recognition in this petition because it seems like a missed opportunity.
But then again, perhaps it is better if it's classed as a seperate disorder. I hope that there is an equally large scale effort for this as there was PSSD.
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby sylv » Tue Jun 11, 2019 9:06 am

The problem is, the SSRI induced emotional blunting is not listed and even defined in a common clinical dictionaries used for classifying ( coding ) side effects during clinical trials. You would think psychiatry uses very special dictionaries and methodology especially designed for catching any mental safety issues but it's not true. They use a common lowest acceptable industry standard, enough what regulator wants to get drug onto market but not more. Academical applied research is much smaller, but still many clinical concentrate more on efficiency than side effects. One prominent psychiatry figure was quoted to say " You cannot let the tail ( side effects ) wag the dog (efficiency ) .

EMA also said the main problem with PSSD is a lack of its coding and definition in their regulatory dictionary.

In overall, while the sexual dysfunction when taking drug is a well established ( just percentages differ across studies ) emotional blunting is not - purely anecdotal. Doesn't matter some doctors publicly acknowledge emotional blunting may affect as much as 20% SSRI patients. In clinical studies It's probably buried in a clinical Individual Case Study Reports (ICSR ), which are commonly regarded as "commercial secret" and not available for reanalysis to public, or even non-company affiliated scientists and doctors. Ask Healy et al how much problem they had with reanalysis of Study 329. Even a court was unable to get full data from GlaxoSmithKline

If you don't have a solid evidence in literature about emotional blunting while on a drug, it's logical you won't have the same about persisting after withdrawal of drug. Scientists also wouldn't risk their publication got burn by peer review because controversial statement. So depression is a commonly used as sloppy, but acceptable explanation.

Also trial design is totally not adequate to what is seen in a real clinic setting. How many of us perfectly tolerated SSRI and only after long, repetitive use crippling emotional blunting and sexual dysfunctions appeared ? In my personal opinion - many. The clinical trials are usually either one signle on-off lasting 4 weeks to maximum 8, 12 weeks long.


perhaps it is better if it's classed as a seperate disorder. I hope that there is an equally large scale effort for this as there was PSSD.


IMO persistent emotional blunting and persistent sexual dysfunction induced by SSRI are ONE disorder, just differ in variation what dominates more with regard to specific individual.
Last edited by sylv on Tue Jun 11, 2019 12:04 pm, edited 5 times in total.
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby GIXXER » Tue Jun 11, 2019 9:31 am

Really??? You people can't be happy that PSSD is finally being aknowledge by a governing body? Its taken years to get to this point.
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby sylv » Tue Jun 11, 2019 9:34 am

GIXXER wrote:Really??? You people can't be happy that PSSD is finally being aknowledge by a governing body? Its taken years to get to this point.


just blunted. Don't blame many of us for that
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby omar90 » Tue Jun 11, 2019 9:42 am

I think this is great news and a big step forward for us

But it does highlight how absurd it is to call our condition "pssd", we basically only have recognition of half of our syndrome.
Fluoxetine 2008-13, PSSD thereafter

Condition worsened after 4 weeks on Setraline in 2014
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby Kk88 » Tue Jun 11, 2019 9:57 am

Great news! Well done everyone involved
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby link11 » Tue Jun 11, 2019 11:55 am

GIXXER wrote:Really??? You people can't be happy that PSSD is finally being aknowledge by a governing body? Its taken years to get to this point.


Well like I said, I never got the sexual side effects from SSRI'S. I'm happy for everyone here but like someone said above, it's like only half the syndrome has been acknowledged.

If I am honest though, I feel the term PSSD never did enough to highlight the emotional numbing side effect of these drugs, as it was not included in the title at all. I think this was a big mistake.

I guess it means we will have to treat this as a seperate syndrome instead. It's unfortunate but it seems like this will just have to be a whole other battle.
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Re: EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs (RxISK 11 june 2019)

Unread postby sylv » Tue Jun 11, 2019 11:59 am

Wouldn't be a nice idea If we wrote collaboratively letter from PSSD community to say thanks to PRAC members for recognising our condition ?

Of course partly recognising but it's a good start anyway

link11 wrote:
I guess it means we will have to treat this as a seperate syndrome instead. It's unfortunate but it seems like this will just have to be a whole other battle.


When whole "persistent sexual dysfunction" become less controversial and more publications appears, we have to count someone will say " some patients also report very distressing emotional symptoms too". And the next publication will quote a previous one. Over and over. Thats how it's work

Would be nice if we put Emotional Blunting while on drug into wikipedia at least. There is enough literature fulfilling their MEDRS criteria. But it would need to be done VERY CAREFULLY, so many medical whitewashers are waiting for their new target.
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