Warnings new update about persistent sexual dysfunction for antidepressants

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, 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.

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.

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.

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.

Learn more at: Updated warnings about persistent sexual dysfunction for antidepressants | Therapeutic Goods Administration (TGA)