Health Canada announces that it reviewed the potential risk of persistent or worsening sexual dysfunction, as well as the appearance of new symptoms of sexual dysfunction after stopping Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin-norepinephrine Reuptake Inhibitor (SNRI) treatment. The safety review was triggered by information received from the European Medicines Agency, which was contacted by a group of physicians and scientists concerned that stopping SSRI or SNRI treatment could result in persistent, worsening, or new symptoms of sexual dysfunction. It is well known that continued treatment with SSRIs and SNRIs can cause sexual problems (dysfunction) such as low sexual desire, problems maintaining an erection, orgasm problems, genital or nipple numbness, etc.
In Canada, SSRIs authorized for use include citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine, and SNRIs authorized for use include desvenlafaxine, duloxetine, levomilnacipran and venlafaxine.
Health Canada reviewed information from published and unpublished population-based (epidemiologic) studies and case reports of individual patients. Information was obtained from searches of international databases of published literature, drug manufacturers, physicians concerned about this issue, as well as searches of the Canada Vigilance database. Epidemiologic studies reporting sexual dysfunction with SSRIs or SNRIs use were not specifically designed to assess a link between treatment discontinuation and persistent, worsening, or new symptoms of sexual dysfunction, so were not included because of concerns about the accuracy of their findings.
Health Canada's review of case reports focused on the outcome of persistent sexual dysfunction. Existing assessment tools were not designed to assess the link between treatment discontinuation and changes in patient symptoms (such as worsening of existing symptoms, or the appearance of new symptoms of sexual dysfunction). Of the 58 case reports of sexual dysfunction, 43 cases (16 Canadian, 27 international) of persistent sexual dysfunction were considered possibly linked to previous use and discontinuation of SSRI or SNRI treatment. The remaining 15 cases could not be assessed because there was not enough information. In some of these case reports, symptoms lasted long after treatment discontinuation (weeks to years).
Health Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction. Health Canada's review could not make conclusions about worsening or new symptoms of sexual dysfunction as the studies were not designed to assess this. Health Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00254
In Hong Kong, there are registered pharmaceutical products containing SSRIs and SNRIs, including citalopram (15 products), escitalopram (33 products), fluoxetine (23 products), fluvoxamine (4 products), paroxetine (11 products), sertraline (21 products), vortioxetine (3 products), desvenlafaxine (3 products), duloxetine (12 products), milnacipran (2 products) and venlafaxine (31 products). All products are prescription-only medicines. There is no registered pharmaceutical product containing vilazodone and levomilnacipran.
So far, the Department of Health (DH) has received adverse drug reaction related to citalopram (one case), escitalopram (2 cases), fluoxetine (one case), sertraline (2 cases), vortioxetine (3 cases), desvenlafaxine (9 cases), duloxetine (one case) and venlafaxine (3 cases), but these cases are not related to sexual dysfunction. The DH has not received any case of adverse drug reaction related to fluvoxamine, paroxetine and milnacipran.
In light of the above Health Canada’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Jan 7, 2021
Issued at HKT 16:00
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