Health Canada announces that it completed a safety review on oral retinoids and erectile dysfunction in 2016. The review found that there may be a link between the use of oral isotretinoin products and the risk of erectile dysfunction. At the time of the review, the Canadian product monograph (CPM) for Epuris already included this risk. The CPMs for the other isotretinoin-containing products that were on the market were subsequently updated to include erectile dysfunction, thereby aligning the product safety information for all isotretinoin products.
In 2023, following the publication of a report by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) on the risk of sexual dysfunction with the use of isotretinoin, Health Canada reviewed the potential risk of additional sexual dysfunction-related events, including persistent sexual dysfunction after drug discontinuation. At the time of this review, the CPMs for isotretinoin-containing products were not consistently labelled for these additional events.
Sexual dysfunctions are a group of disorders that can affect a person’s ability to engage in sexual activity. Sexual dysfunction-related events include, but are not limited to, erectile dysfunction, vulvovaginal dryness, and reduced libido.
Health Canada reviewed the available information from searches of the Canada Vigilance database and the scientific literature. Health Canada identified 111 cases (11 Canadian and 100 international) reporting 1 or more events of sexual dysfunction, including persistent sexual dysfunction after drug discontinuation, related to the use of isotretinoin. In just over half of the events, the sexual dysfunction was reported as persisting for months to years following drug discontinuation. The average age was 23 years in cases where age was provided. These cases overall did not include sufficient clinical information, including details on mental health at the time of sexual dysfunction, to definitively determine a link between isotretinoin use and sexual dysfunction. However, given the timing of the events, a link could not be ruled out.
Health Canada also reviewed 6 articles published in the scientific literature. The level of evidence in these articles was considered limited, but some reported sexual dysfunction with isotretinoin use, including those which continued after drug discontinuation.
Based on the totality of the evidence reviewed, a link between isotretinoin and sexual dysfunction, including persistent sexual dysfunction after drug discontinuation, could not be ruled out. The evidence reported was primarily for erectile dysfunction, reduced libido, and vulvovaginal dryness. Despite the limited available evidence, the young age of the intended population, the number of reported cases, and the significant impact of the adverse events are factors that warrant a precautionary approach for this risk.
Health Canada’s review of the available information concluded that a link between isotretinoin and the risk of sexual dysfunction, including persistent sexual dysfunction after drug discontinuation, could not be ruled out.
Health Canada will work with the manufacturers to update and align the CPM for all isotretinoin-containing products to include this potential risk. Health Canada will also work with the manufacturers to implement additional measures to inform patients of this potential risk. Health Canada will inform healthcare professionals about this update through a Health Product InfoWatch communication.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1717527382406#wb-auto-4
In Hong Kong, there are 13 registered pharmaceutical products containing isotretinoin. All products are prescription-only medicines. So far, with regard to isotretinoin, the Department of Health (DH) has received 2 cases of adverse drug reaction, but the cases were not related to sexual dysfunction.
Related news was previously issued by MHRA and Health Sciences Authority, and was posted on the Drug Office website since 27 Oct 2017, with the latest update posted on 16 Dec 2023. Letters to inform local healthcare professionals were issued by the DH on 27 Oct 2017 and 27 Apr 2023. Currently, the sales pack or package insert of locally registered isotretinoin-containing products should include warnings on sexual dysfunction including erectile dysfunction and decreased libido. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Jul 26, 2024
Issued at HKT 16:00
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