Updated warnings about persistent sexual dysfunction for antidepressants

Summary

The Product Information (PI) documents for all selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) have been aligned to reflect the risk of sexual dysfunction persisting in some patients after drug cessation.

Sexual dysfunction is a known risk of SSRIs and SNRIs and these medicines already carry this warning. However, the caveat that this effect can persist even after patients stop treatment was not present in some of the PIs in this drug class.

Sexual dysfunction can refer to disorders of sexual drive (reduced or loss of libido), arousal and orgasm, and ejaculation. Patients may also report associated painful intercourse (dyspareunia), prolonged erection (priapism) or genital numbness. These effects can persist for weeks to years and can significantly harm patients’ quality of life.

Persistent sexual dysfunction after treatment is stopped is thought to be rare^[1]. However, these symptoms are likely to be underreported and their prevalence is not currently known.

What health professionals should do

Health professionals should be alert to this issue and consider if current or previous antidepressant use could be a factor in patients reporting sexual dysfunction.

This adverse event is likely to be underreported and we encourage health professionals to report if they are suspicious of an association.

Background

SSRIs and SNRIs are widely used antidepressants in Australia. They are approved for major depression and anxiety disorders (obsessive compulsive disorder (OCD), social anxiety disorder, panic disorder and generalised anxiety disorder).

In addition to the original brands, there are numerous generic versions of these medicines.

Medicines in this class include:

• SSRIs – citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline.
• SNRIs – desvenlafaxine, duloxetine and venlafaxine.

Cases of persistent sexual dysfunction 

We have received 89 reports describing sexual dysfunction with an SSRI or SNRI in our Adverse Event Management System database (to April 2024). Of these, 4 described persistent sexual dysfunction after treatment was stopped. The 3 men and one woman ranged in age from 18 to 42. Reported symptoms included difficulty reaching orgasm, weakened orgasms, erectile dysfunction and reduced penile sensation. The effects persisted for 12 months to 3.5 years. 

Cases of persistent sexual dysfunction have also been reported globally. One study of SSRIs, SNRIs, finasteride and isotretinoin identified 300 case reports^[2]. The majority were associated with SSRIs and SNRIs (218 of 300 cases) with escitalopram, citalopram, paroxetine, sertraline, and fluoxetine accounting for 62% (186 out of 300 cases). Patient ages ranged from 15 years to 66 years with most patients being male (170 males vs 49 females). Duration of treatment ranged from a single dose to more than 16 years. In many cases, sexual dysfunction only presented or became worse when treatment was stopped.

PI updates

The PIs of all SSRIs and SNRIs already warn of the risk of sexual dysfunction during use of these medicines.

Three products – desvenlafaxine, sertraline and venlafaxine – already carry warnings about persistent sexual dysfunction.

Updated warnings were needed for 6 products: citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, and paroxetine, as follows:

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.

The latest Product Information (for health professionals) and Consumer Medicine Information (for patients) for these antidepressants are available on TGA eBusiness services.

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

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Medicines Safety Update is written by staff from our Pharmacovigilance Branch.

Editor: Dr Megan Hickie

Deputy Editor: Aaron Hall

Contributors: Renae Mura & Dr Steph Cheung