Isotretinoin and sexual dysfunction in men
Research type
Research Study
Full title
Isotretinoin and sexual dysfunction in men: a single-centre retrospective study
IRAS ID
342506
Contact name
Oliver Johnson
Contact email
Sponsor organisation
Wirral University NHS Teaching Hospital
Duration of Study in the UK
0 years, 0 months, 31 days
Research summary
Isotretinoin is an oral derivative of vitamin A which has been used in the management of moderate to severe acne vulgaris for over forty years. In October 2023, strict new prescribing measures were implemented in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). The prescribing changes were initiated based on the findings of the ‘Isotretinoin Expert Working Group’ formed by the Commission on Human Medicines. One of the new changes is that clinicians must now inform patients of a possible association between isotretinoin and sexual dysfunction. This includes counselling patients about the possibility of developing erectile dysfunction, reduced libido, orgasm difficulties and genital hypoaesthesia whilst on treatment. Patients must also be informed that some people have experienced continuation of these symptoms even after treatment has been discontinued. Because of these findings, the summary of product characteristics for Isotretinoin now states that ‘Isotretinoin may be associated with sexual dysfunction’ and symptoms such as erectile dysfunction and decreased libido are ‘possible’ side effects of unknown frequency. The lack of certainty about a causal association and the possibility of long-lasting side effects is understandably alarming for patients. As a result of discussions around the possible effects, patients decline effective treatment and instead live with the sometimes immense physical and psychological morbidity associated with severe acne. To date, there have been no high-quality studies which aim to establish the true incidence of sexual dysfunction among patients receiving treatment with isotretinoin. Furthermore, evidence that symptoms can potentially persist after treatment discontinuation is lacking and further studies are required to establish how often patients on treatment experience these symptoms. The aim of this retrospective study is to assess the frequency of sexual dysfunction side effects in men who received treatment with isotretinoin over a 2 year period.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
24/PR/0422
Date of REC Opinion
30 Apr 2024
REC opinion
Unfavourable Opinion