European Medicines Agency reviewing PSSD in September

ssri
pssd
antidepressant

#1

It seems that European Medicines Agency is going to undertake a wide EU review of a signal regarding the pssd signalation.
Please check the link below:

http://www.pssdforum.com/viewtopic.php?f=41&t=2280


#2

Woah. This is extremely important.

After a recent EMA review, the UK regulator added erectile dysfunction to the Accutane side effects list.

Accutane patients got this success by emailing the EMA members in their country.

https://hansard.parliament.uk/commons/2018-03-07/debates/50B8D4FD-6708-4008-9A49-000CC124961D/Accutane


#3

From experience, the actions to take are:

  • 1: Contact the EMA PRAC members in your country.

  • 2: Do this by browsing the minutes and related documentation on the site. Find the email addresses.

  • 3: Write a polite and factual email highlighting your experience. It is critical that you have filed an adverse reaction report in your country. Tell them that you have done this.

  • 4: If you are able - ask for an in-person meeting with them. This shows you are ultra serious.

Make your correspondence with the regulatory members polite and factual.

Encourage as many people as possible to make contact with the regulators.

Please do this now - it is key to our success.

We did this with Accutane. Now we do it again with PSSD.


#4

All done Pete, but i can’t find the minutes for the september meeting.


#5

It may be they are not published yet.

They are good at adminstering their site, so expect them to appear once they have been processed etc.


#6

But i think they’ll publish it once the meeting is done, or you think before?
If they will just add a warning, that will be no big deal for us, because we need formal recognition of problem, we have to be recognised as sufferers of a iatrogenic syndrome
Let’see what happens.


#7

If they just add a warning to the side effects list - that’s progress.

We need to take every small win we can get.

In time we make 10,000 small wins - then we are cured.


Community Campaigns
#8

@Lw77 Do you have the link to the individual PRAC members’ names / emails?

For sharing here.


#9

I think it should be this:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/PRAC/people_listing_000112.jsp&mid=WC0b01ac058058f328


#10

Great!

If you have an account over at PSSD forum - can you link them to our site?

We have added to our live campaigns:

It’d be cool if you could link them to above.


#11

Sorry but i haven’t understood what i have to do…
What dp you want me to link?


#12

Post this link at pssdforum:

So that the pssdforum people know our site.


#13

Ah ok, of course i can.
This site is well known.

Done:
http://www.pssdforum.com/viewtopic.php?f=10&t=2287&sid=107bd0afafc2bd081ceabf4d51435e15


#14

This is great news! Essential that everyone in Europe with PSSD contacts their national representative. Thanks guys for bringing this to the forefront.

Just FYI, PRAC added sexual side effects to Ro/Accutane label and they didn’t even intend to investigate that particular side effect during their initial review. The focus was risk of the drug causing depression, yet they took our many complaints to heart and launched an investigation into sexual sides, resulting in the recent label change. (Whether manufacturers followed their mandate is a different story)

They appear to be decent people, less under influence of the pharmaceutical companies than the FDA CDER.


#15

Yes - and you deserve the credit for bringing up all this in the first place. Your emails a few months back had a big impact! :slight_smile:

The result was the label change enforced in the UK. We can reasonably think our efforts are working.

And there are now more related warnings, for readers’ interest. Details here in Spanish:


#16

Thanks Pete, but the credit goes to the entire grapevine, from the parent’s group, to the people who reported to PRAC, to the regulators who made it happen.


#17

Next thing is that we need the same attention on the PSSD side.

The victory of getting ‘erectile dysfunction and libido loss’ added to the PIL, for SSRI.

That would be a big win!


#18

Guys in Italy there is an important Psychiatrist from Florence, Prof. Fiammetta Cosci, that is running up a study on PSSD.
She has two questionnaires: one for male and one for female PSSD sufferers.
She is one of the few that is trying to do something very important for us, raising awareness of the problem and studying it.
So i post the link for the questionnaires:

For male:

https://docs.google.com/forms/d/e/1FAIpQLSdVBEJovYl7g0P2DBXiO_SAOw3qL3T-eDKYGlA9ycPF9t3BwA/viewform?usp=sf_link

For female:

https://docs.google.com/forms/d/e/1FAIpQLSfe-Dzg8stMPnamTGH4NfEUNdHK23vVgFl9ikQLP6aT6maNrw/viewform?usp=sf_link

Please send her the questionnaires so she can study the problem and help us.
Thank’s to anyone who will participate

Edit: after the questionnaires there can be a second part, that will be a skype interview, but only for who is interested. You can only fill the questionnaire if you are not interested in the second part😀


#19

The minutes of PRAC were released, it seems that some signals coming from Duloxetine, but maybe and hopefully the ones from other SSRI will be taken in account. I don’t know what you think of this but maybe is a good sign.

Below i copied the link of PSSD forum were transcripted the part of interest, so you don’t have to search all the document if you don’t want to.

http://www.pssdforum.com/viewtopic.php?f=41&t=2280&hilit=Urgent&sid=923398902a20403242b09e5f08e4e9e9&start=40

Best wishes to everyone : )


#20

Good news!

Given that the review of PSSD was introduced by the industry, it probably means they are trying to cover their asses in anticipation of the eventual widespread exposure of the condition.

Whatever it takes to gain acknowledgement!