Isotretinoin (Roaccutane▼): contribute to expert review
A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible association between isotretinoin and suspected psychiatric and sexual disorders. We invite patients and their families, healthcare professionals, researchers and organisations to contribute views and information to the review.
Post-publication note; April 2023
The expert review of isotretinoin concluded in April 2023 for more information. In October 2023 we published new advice to strengthen the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health and sexual function issues. The advice in this article is therefore superseded and all healthcare professionals should consult the October 2023 Drug Safety Update when referring patients and when prescribing or dispensing isotretinoin.
Isotretinoin (Roaccutane▼, Reticutan▼, and Rizuderm▼) is indicated for severe acne that is resistant to adequate courses of standard antibacterial or topical therapy. Although an effective treatment for severe acne, isotretinoin has significant risks that require specialist oversight, including teratogenic effects if pregnancies are exposed and the potential for psychiatric reactions and sexual dysfunction. We recently published a reminder of important risks and precautions.
An Expert Working Group is reviewing the available evidence relating to isotretinoin, and 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.
We invite patients and their families, healthcare professionals, researchers and organisations to contribute views and information to the review.
Contribute to the Call for information.
Details about the call for information, including what and how to submit, are available via the consultation website.
Call for reporting
Isotretinoin is a black triangle medicine and all suspected adverse reactions, including any sexual and psychiatric adverse reactions, should be reported via the Yellow Card scheme.
Reports can be made of suspected reactions experienced at any time, including historic adverse experiences with medicines. Please include in the report as much detail as possible, particularly if a side effect continued or started after treatment was stopped. Information about medical history, any concomitant medication, onset, treatment dates, and product brand name should also be included.
Report to the Yellow Card scheme electronically using:
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the Yellow Card app; download from the Apple App Store or Google Play Store
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some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)
Article citation: Drug Safety Update volume 14, issue 4: November 2020: 5.
Last updated 16 November 2020 + show all updates
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Added to DSU November
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First published.