Quoting:
rxisk.org/ema-acknowledges-...
On May 31, 2019, we received the following message from EMA:
Dear Professor Healy,
We are writing to you to inform you that the review by EMA’s safety committee PRAC into sexual dysfunction with SSRIs and SNRIs has now concluded. We would like to take this opportunity to thank you and the patients involved for your important contribution in supporting EMA in its role of supervising medicines’ safety in Europe. Patient reports such as the ones you submitted are essential to gain a better insight into a medicine’s safety profile and were a valuable contribution to this review.
On Thursday 16 May, PRAC concluded that sexual dysfunction, which is known to occur with treatment with SSRIs and SNRIs and usually resolves after treatment has stopped, can be long-lasting in some patients, even after treatment withdrawal. In addition to the patient reports provided, PRAC also assessed data from the published literature, clinical and non-clinical studies, as well as data gathered by the marketing authorisation holder in its safety databases and reports collected through the Eudravigilance database.
Based on this data it is currently not known how long these symptoms can persist, and the issue will continue to be closely monitored.
The outcome of the review will be made public on EMA’s website on 10 June 2019:
ema.europa.eu/en/human-regu...
Quoting:
ema.europa.eu/en/documents/...
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, to amend the product information as described below (new text underlined):
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....
