URGENT - European Medicines Agency reviewing PSSD in 5 days

New members can only post here until they introduce themselves
omar90
Posts: 138
Joined: Tue Jan 17, 2017 2:10 pm
Contact:

URGENT - European Medicines Agency reviewing PSSD in 5 days

Unread post by omar90 »

Hello everyone,

I have been pestering the UK regulatory body for prescription medicines for the last six months just to keep up any pressure I can for formal recognition of out syndrome. In their most recent correspondence they made me aware of a EU review of SSRI side effects and PSSD (SEE BELOW)




" Since our last correspondence the European Medicines Agency (EMA) has announced that they are going to be undertaking an EU wide review of a signal regarding this issue. The MHRA is contributing to this review and we will keep in touch with you on the progress of this procedure. The first discussion is due to be held at the September meeting of the Pharmacovigilance Risk Assessment Committee.

Public minutes of the PRAC meetings for your information are available at http://www.ema.europa.eu/ema/index.jsp? ... nt_listing_
000353.jsp&mid=WC0b01ac05805a21cf

Since different patients have reported a wide variety of different symptoms, the exact definition and terms used to classify sexual side effects that seem to persist beyond the half life of the SSRI is difficult. The European review will look at SSRIs and persistent sexual dysfunction and persistent genital arousal. It is hoped that the definitions and terminology will be fully evaluated and better defined during this review.

We don’t routinely arrange meetings with individuals to discuss reports of adverse drug reactions
but we will endeavour to keep in touch on any progress on this issue."




I think we all need to contact members of the Pharmacovigilance Risk Assessment Committee before this meeting takes place in order to raise awareness of PSSD and try and explain this very complicated syndrome. Each EU member state sends a representative to the committee. You can find their contact details here:

http://www.ema.europa.eu/ema/index.jsp? ... 058058f328

It also has links to independent experts, health care professional representatives and patient representatives. I'm assuming no patient representatives for PSSD will be present at the committee meeting.

I just think it would be a really great idea to try and start an intensive lobbying campaign in the next week or so before the meeting is held to try and have our voices heard.

We could also try and put Dr Melcangi and any other scientists in touch with members who are going to be present to try and give our condition more formal scientific backing.

Its becoming increasingly clear to me that so much of our problem regarding recognition comes down to a confusion of what the condition is and its varied nature so trying to clearly outline the symptoms to the committee members maybe a good start.

What do people think?

Thanks,

Sam
Last edited by omar90 on Wed Aug 29, 2018 6:25 am, edited 1 time in total.
Fluoxetine 2008-13, PSSD thereafter

Condition worsened after 4 weeks on Setraline in 2014
Numby
Posts: 152
Joined: Tue Sep 19, 2017 11:55 am
Location: Germany
Contact:

Re: European Medicines Agency reviewing PSSD in September - Time to lobby the committee?

Unread post by Numby »

That's great news. Personally, I am absolutely willing to contact the German members. There’s not much time left, so I’d like to know what everybody thinks about the question what to write?

Should I just let them know that I (or we as a community) think it’s great that the issue is finally being discussed at a higher level?

Or, if giving details as you suggest, what exactly do you think I should write about? Just a list of symptoms? Should I include reference to scientific research?
lw77
Posts: 89
Joined: Wed Aug 01, 2018 11:29 am
Contact:

Re: European Medicines Agency reviewing PSSD in September - Time to lobby the committee?

Unread post by lw77 »

Excuse me, but i have not understood well.
Is the EMA going to examine the complaints on permanent sexual dysfunction that have received through the various countries?
Is a meeting focused on PSSD?
The first link doesn't seem to work.
fema4psyciatrists
Posts: 480
Joined: Sun Apr 24, 2016 4:46 pm
Contact:

Re: European Medicines Agency reviewing PSSD in September - Time to lobby the committee?

Unread post by fema4psyciatrists »

Thank You for posting this. I have sent an email to June Munro mentioning that I am upset that this happened and there was no leaflet warning, now I expect the MHRA to do whatever they can to rectify the situation and to keep me updated. Not an unreasonable request. I suggest everybody that can get involved, also, please do. It is nearly September.
RIP Ali 23 years old
RIP Kevin Goodreau 28 years old
RIP Petar 23 years old
RIP Mary Koback 22 years old
RIP David Stofkooper 23 years old
RIP SadBoy
RIP Kata Balint 28 years old
User avatar
anacleta
Posts: 695
Joined: Fri Jan 23, 2015 5:47 am
Contact:

Re: European Medicines Agency reviewing PSSD in September - Time to lobby the committee?

Unread post by anacleta »

Thank you for these advances and for being determined to keep in touch with the pharmacovigilance agency
lw77
Posts: 89
Joined: Wed Aug 01, 2018 11:29 am
Contact:

Re: European Medicines Agency reviewing PSSD in September - Time to lobby the committee?

Unread post by lw77 »

We contacted our referent for italy, i think everyone should do for it's own country.
omar90
Posts: 138
Joined: Tue Jan 17, 2017 2:10 pm
Contact:

Re: URGENT - European Medicines Agency reviewing PSSD in 5 days

Unread post by omar90 »

People still have time to contact members of the Pharmacovigilance Risk Assessment Committee who are going to be discussing the issue of PSSD - they are not specialists on the subject and will not be consulting with scientists who have been researching on PFS and our condition.

What I would suggest telling them:

Your story

ALL of your symptoms - emotional, sexual, cognitive etc

3 articles in the media:

https://www.theguardian.com/society/201 ... g-term-use
https://www.theguardian.com/lifeandstyl ... -felt-numb
http://www.dailymail.co.uk/health/artic ... -life.html

2 Scientific papers that mention PSSD

https://www.sciencedirect.com/science/a ... 9515317896
https://www.sciencedirect.com/science/a ... 2117300720

Its important that we stress that this is a life debilitating condition that often includes more than just sexual side-effects.

I'm going to email every committee member and the chair.
Fluoxetine 2008-13, PSSD thereafter

Condition worsened after 4 weeks on Setraline in 2014
fema4psyciatrists
Posts: 480
Joined: Sun Apr 24, 2016 4:46 pm
Contact:

Re: URGENT - European Medicines Agency reviewing PSSD in 5 days

Unread post by fema4psyciatrists »

My 3 UK representatives haven't replied yet, and I don't think they will find it a priority to do so.

More from UK contact them too please.!!!

Should I phone these *******?
RIP Ali 23 years old
RIP Kevin Goodreau 28 years old
RIP Petar 23 years old
RIP Mary Koback 22 years old
RIP David Stofkooper 23 years old
RIP SadBoy
RIP Kata Balint 28 years old
omar90
Posts: 138
Joined: Tue Jan 17, 2017 2:10 pm
Contact:

Re: URGENT - European Medicines Agency reviewing PSSD in 5 days

Unread post by omar90 »

Great that you have sent!

Who is the third member, I have Julie Williams and Patrick Batty?

Albert van der Zeijden of Affiliation International Alliance of Patients' Organizations (IAPO) looks like someone who could be useful in the long run.

I wouldn't call them because we don't want to harass, we just want our information read by them and then to let them make a decision. I think we just have to see this a as a first step of raising awareness among committee members of the issue that can be greater illuminated as the year goes on.
Fluoxetine 2008-13, PSSD thereafter

Condition worsened after 4 weeks on Setraline in 2014
chemistry
Posts: 195
Joined: Mon Jul 27, 2015 7:38 pm
Contact:

Re: URGENT - European Medicines Agency reviewing PSSD in 5 days

Unread post by chemistry »

Can you send an email if you're not from europe?
Brief Symptoms:
PE - Anhedonia, less emotions - Test Atrophy - Numb body - Lowered libido = ED
24/7 tension, stress. Worse with lack of sleep, hungry, ill
"Pure-O"
Visual Snow Syndrome + DP/DR + Tinnitus
Insomnia, Fatigue
see intro for more
Post Reply

Who is online

Users browsing this forum: No registered users and 7 guests