11111ADR that result in revision of patient information
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| Australia: Updated warnings about persistent sexual dysfunction for antidepressants |
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The Therapeutic Goods Administration (TGA) announces that 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. However, these symptoms are likely to be underreported and their prevalence is not currently known.
Medicines in this class include:
• SSRIs – citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline.
• SNRIs – desvenlafaxine, duloxetine and venlafaxine.
TGA has received 89 reports describing sexual dysfunction with an SSRI or SNRI in its 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. 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.
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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/updated-warnings-about-persistent-sexual-dysfunction-antidepressants
In Hong Kong, there are registered pharmaceutical products containing SSRIs and SNRIs, including citalopram (12 products), escitalopram (34 products), fluoxetine (21 products), fluvoxamine (4 products), paroxetine (8 products), sertraline (20 products), desvenlafaxine (5 products), duloxetine (18 products), and venlafaxine (27 products). All products are prescription-only medicines.
So far, the Department of Health (DH) has received adverse drug reaction with regard to citalopram (2 cases), escitalopram (2 cases), fluoxetine (22 cases), sertraline (5 cases), desvenlafaxine (13 cases), duloxetine (2 cases) and venlafaxine (3 cases), but these cases are not related to sexual dysfunction. The DH has not received any case of adverse drug reaction with regard to fluvoxamine and paroxetine.
Related news was previously issued by Helath Canada and was posted on the Drug Office website on 7 Jan 2021. Letters to inform local healthcare professionals were issued by the DH on 7 Jan 2021. In Feb 2022, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack labels and/or package inserts of locally registered pharmaceutical products containing SSRIs and SNRIs should contain safety information about the risk of long-lasting sexual dysfunction. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Friday, May 24, 2024
Issued at HKT 17:30
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