isotretinoin and sexual dysfunction

Last edited 10/2023 and last reviewed 11/2023

Isotretinoin and sexual dysfunction

• use of isotretinoin may be associated with sexual dysfunction (1)
  • suspected adverse side effects include:
    • erectile dysfunction
    • decreased libido,
    • vulvovaginal dryness
    • orgasm difficulties and
    • genital hypoaesthesia
  • patients should be asked about the presence of symptoms or signs of sexual dysfunction prior to starting treatment with isotretinoin, and be monitored for the development of new sexual disorders during treatment
    • age and maturity of the patient should be considered in choosing the most appropriate counselling approach, including giving the option to discuss without parents or carers present where appropriate
    • appropriate guidelines should be considered when providing advice about sexual health to young people
• isotretinoin has both serotonin reuptake inhibiting and 5 alpha-reductase inhibiting properties, but it is not clear whether the problem stems from either of these actions (3)

Advice for healthcare professionals (2):

• all patients must be counselled about the benefits and risks of treatment before isotretinoin is prescribed, including possible mental health and sexual function side effects; we also ask the referrer (usually the GP) to provide information about isotretinoin to the patient and provide counselling (where possible) regarding the benefits and risks of isotretinoin treatment
• isotretinoin is teratogenic; all patients of childbearing potential must be entered into the Pregnancy Prevention Programme
• prescribers should assess patients’ mental health before prescribing isotretinoin including the use of patient-reported outcome measures
• ask patients about any sexual function concerns before prescribing isotretinoin
• give the patient sufficient time to consider, reflect and ask questions before starting isotretinoin treatment
• use the new regulatory risk minimisation materials with all patients: Acknowledgement of Risk Form, Patient Reminder Card, Pharmacist Checklist
• the Lead Prescriber, who initiates isotretinoin treatment, must have expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements
• initiation of isotretinoin treatment in patients under 18 years of age now requires agreement by 2 independent healthcare professionals that there is no other appropriate effective treatment before it is prescribed. This means that isotretinoin should only be prescribed for severe acne that is resistant to adequate courses of standard therapy
• review patients approximately 1 month after initiation of treatment in a face-to-face (in-person) appointment
• monitor patients for side effects including mental health and sexual function side effects at each follow up appointment including objective mental health patient reported outcome measures
• any healthcare professional involved in the treatment of patients with acne, particularly prescribers of isotretinoin, should review the full details of the new requirements in the Report of The Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group
• report suspected adverse drug reactions associated with isotretinoin on a Yellow Card

Reference:

• Drug Safety Update volume 16, issue 9: April 2023: 1.
• Drug Safety Update volume 17, issue 3: October 2023: 1.
• Healy D et al. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med. 2022;33(1):65-76. doi: 10.3233/JRS-210023. PMID: 34719438; PMCID: PMC8925105.