Post-publication note: October 2021
An Expert Working Group is reviewing the available evidence relating to isotretinoin. This review will advise whether the MHRA should take additional regulatory action, for example improving the information for patients to help minimise the risks of psychiatric and sexual side effects, suspected to be associated with isotretinoin. Please see the expert review website for further information and updates
Advice to healthcare professionals:
- be aware of reports of sexual side effects, including erectile dysfunction and decreased libido, in patients taking oral isotretinoin, indicated for severe acne
- the exact incidence of these adverse reactions is unknown but considering the number of patients in the UK taking the medicine, reports are understood to be rare
- report any suspected adverse reactions to isotretinoin or other medicines on a Yellow Card
A routine EU review showed that some patients taking isotretinoin had reported sexual dysfunction adverse effects, including erectile dysfunction and decreased libido. One possible mechanism for this effect may be through a reduction in plasma testosterone levels.
The review recommended that sexual dysfunction including erectile dysfunction and decreased libido should be added to the list of side effects in the product information. The package leaflet for patients will include “Problems getting or maintaining an erection and lower libido” as possible side effects.
In the UK, we have received 14 Yellow Card reports of sexual dysfunction associated isotretinoin between the beginning of 1985 and 7 September 2017. In the same time period, there have been 49 reports of erectile or ejaculation dysfunction, and 23 reports of decreased or loss of libido associated with isotretinoin. We estimate that over the past few years, around 30,000 patients (male and female) per year have been treated with isotretinoin (see 2014 Public Assessment Report).
Reminder of risk of mood disorders
Be aware of rare reports of depression, exacerbated depression, anxiety, aggressive tendencies, mood alterations, and psychotic symptoms in association with isotretinoin treatment. Very rarely, suicidal ideation, suicide attempts, and death by suicide have been reported.
Particular care should be taken in patients with a history of depression. Monitor all patients for signs of depression and refer for appropriate treatment if necessary. Further psychiatric or psychological evaluation may be necessary after discontinuation of treatment with isotretinoin.
Call for reporting
The Medicines and Healthcare products Regulatory Agency continually monitors the safety of all medicines. All suspected adverse reactions, including any sexual and psychiatric adverse reactions, should be reported via the Yellow Card Scheme.
Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation. July 2017.
Article citation: Drug Safety Update volume 11, issue 3; October 2017: 3.