European Medicines Agency reviewing PSSD in September

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.

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

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.

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.

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.

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

For sharing here.

I think it should be this:

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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.

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

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Post this link at pssdforum:

So that the pssdforum people know our site.

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

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

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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.

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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:

https://www.icf.uab.cat/ca/download/enllac/assets/pdf/productes/bg/ca/bg312.18c.pdf

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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.

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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!

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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:

For female:

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😀

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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 : )

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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!

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Anyone have any further updates on what came of this?

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I report down here PRAC minutes, that is a sinthesis of September’s 2018 meeting.
You can find it using the link below:

https://www.ema.europa.eu/documents/min … 018_en.pdf

4 October 2018
EMA/PRAC/675727/2018
Inspections, Human Medicines Pharmacovigilance and Committees Division
Pharmacovigilance Risk Assessment Committee (PRAC)
Minutes of the meeting on 03-06 September 2018
Chair: Sabine Straus – Vice-Chair: vacant

New signals detected from other sources
See also Annex I 14.2.

4.2.1. Clomipramine (NAP);
Serotonin and noradrenaline reuptake inhibitors (SNRI)5: desvenlafaxine (NAP);
duloxetine - ARICLAIM (CAP), CYMBALTA (CAP), DULOXETINE LILLY (CAP),
DULOXETINE MYLAN (CAP), DULOXETINE ZENTIVA (CAP), XERISTAR (CAP),
YENTREVE (CAP); milnacipran (NAP); venlafaxine (NAP);
Selective serotonin reuptake inhibitors (SSRI)6: citalopram (NAP); escitalopram
(NAP); fluoxetine (NAP); fluvoxamine (NAP); paroxetine (NAP); sertraline (NAP);
Vortioxetine – BRINTELLIX (CAP)

Applicant(s): Eli Lilly Nederland B.V. (Cymbalta, Duloxetine Lilly, Xeristar, Yentreve),
Generics UK Limited (Duloxetine Mylan), H. Lundbeck A/S (Brintellix), Zentiva k.s.
(Duloxetine Zentiva), various
PRAC Rapporteur: Menno van der Elst
Scope: Signal of persistent sexual dysfunction after drug withdrawal
EPITT 19277 – New signal

Background
Clomipramine is a non-selective monoamine reuptake inhibitor indicated, among others, for the treatment of major depressive disorder. Desvenlafaxine, duloxetine, milnacipran and venlafaxine are serotonin and noradrenaline reuptake inhibitors (SNRIs) indicated, among others, for the treatment of major depressive disorder. Citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline are selective serotonin reuptake inhibitors (SSRIs) indicated, among others, for the treatment of major depressive disorder. Brintellix is a centrally authorised product containing vortioxetine, a psychoanaleptic antidepressant. It is indicated for the treatment of major depressive disorders in adults.

Cymbalta and Yentreve, centrally authorised medicines containing duloxetine, are estimated to have been used by approximately 91,636,000 patients worldwide (all indications) in the period from first authorisations in 2004 to 2017. Milnacipran capsule for major depressive episodes7 is estimated to have been used by more than 8,611,639 patients (corresponding to 15,296,991 patients-months) worldwide in the period from first authorisation in 1966 to 2018. Escitalopram (all indication) is estimated8 to have been used by approximately 402,748,747 patients worldwide in the period from first authorisation in 2001 to 2016. The exposure for fluvoxamine (all indications) is estimated9 to have been approximately 1,560,498 patient treatment years worldwide in the period from first authorisation in 1983 to 2017. Paroxetine (all indications) is estimated10 to have been used by more than 400 million patients worldwide in the period from first authorisation in 1990 to 2017. The exposure to sertraline (all indications) is estimated11 to have been approximately 146,798,100 patient-years worldwide in the period from first authorisation in 1990 to 2017. The exposure for Brintellix (vortioxetine) is estimated to have been approximately 2,429,103 patient-years worldwide in the period from first authorisation in 2013 to 2017. The exposure for fluoxetine (all indications) is estimated to have been approximately 121,620,000 patient-years worldwide in the period from first authorisation in 1986 to 2017.

Following some ongoing procedures, where some EU Member States have reviewed information on persistent sexual dysfunction for SSRIs and SNRIs, including spontaneous data in EudraVigilance (EV), recent literature and a petition from a group of professors, psychiatrists and related healthcare professionals (HCPs) concerning persistent sexual disorders with SSRIs and SNRIs, where authors refer to literature cases of genital anaesthesia, persistent genital arousal disorder (PGAD) and post-SSRI sexual dysfunctions (PSSD) and postulate changes in product information, risk minimisation measures taken by MAHs and communication to both HCPs and patients, a signal of persistent sexual dysfunction after drug withdrawal was identified by EMA. The Netherlands confirmed that the signal needed initial analysis and prioritisation by the PRAC.

Discussion
Having considered the available data, including a publication in the International Journal of Risk & Safety in Medicine by Healy D. et al.12 and 574 case reports retrieved for duloxetine in EV with relevant MedDRA HLT13, the PRAC concluded that the signal merits further investigation.
The PRAC appointed Menno van der Elst as Rapporteur for the signal.

Summary of recommendation(s)
• The Lead Member States (LMS)/Rapporteurs for the concerned active substances will review the literature referenced in the above-mentioned petition received by the Agency. In addition, EMA will perform literature reviews, EV data analysis and will explore the feasibility for a pharmacoepidemiological study. Finally, EMA in collaboration with the LMS/Rapporteurs will elaborate on appropriate case definitions for the sexual dysfunction disorders adverse drug reactions (ADRs), using read codes and MedDRA terms, to facilitate further assessments.
• A 30-day timetable was recommended for the assessment of this review leading to a further PRAC recommendation.

5 Indicated in the treatment of major depressive disorder (MDD)
6 Indicated in the treatment of major depressive disorder (MDD)
7 Ixel. Joncia, Dalcipran, Tivanyl, Savella, Toledomin, Milnacipran Pierre Fabre
8 By H. Lundbeck A/S
9 By Mylan
10 By GlaxoSmithKline Research & development
11 By Pfizer
12 Healy D, Le Noury J, Mangin D. Enduring Sexual Dysfunction after Treatment with Antidepressants, 5α-Reductase Inhibitors and Isotretinoin: 300 Cases. Int. J. Risk. Saf. Med. 2018. doi:10.3233/JRS-180744
13 Medical dictionary for regulatory activities – High level term

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