AVRUPA İLAÇ KURUMU (EMA) SSRI VE SNRI GRUBU ANTİDEPRESSANLARIN DAİMİ SEKSÜEL BOZUKLUK YAPABİLECEĞİNİ BİLDİRDİ

klinik farmakoloji dosyası
Haber

Antidepressanlar yalnız geçici değil devamlı seksüel bozukluklara sebep olabiliyor. İlaç kesilse dahi seksüel bozukluklar devam ediyor.

1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI)4 ; selective serotonin reuptake inhibitors (SSRI)5 6 – Persistent sexual dysfunction after drug withdrawal
Authorisation procedure Centralised and non-centralised
EPITT No 19277, PRAC rapporteur(s) Liana Gross-Martirosyan (NL)
Date of adoption 16 May 2019
Recommendation
Having considered the available evidence from EudraVigilance, literature, social media and cumulative reviews provided by MAHs for duloxetine, fluoxetine (Eli Lilly), citalopram, vortioxetine, escitalopram (Lundbeck), fluvoxamine (Mylan), sertraline, desvenlafaxine (Pfizer), paroxetine (GSK), venlafaxine (Almirall), milnacipram (Pierre Fabre) and clomipramine (Alfasigma) the PRAC has agreed that all MAHs of products containing citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline (Selective serotonin reuptake inhibitors (SSRIs)) and all MAHs of products containing duloxetine,
venlafaxine, desvenlafaxine, milnacipram (Serotonin–norepinephrine reuptake inhibitors (SNRIs)) should submit a variation within 2 months

Summary of product characteristics

4.4. Special warnings and precautions for use
Sexual dysfunction
Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

Package leaflet

Warnings and precautions
Medicines like [Invented name] (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

4 Desvenlafaxine; duloxetine; milnacipran; venlafaxine 5 Citalopram; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline 6 Clomipramine and vortioxetine were part of the signal assessment but are not concerned by the recommendation to
update the product information.