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Isotretinoin (Roaccutane?): reminder of important risks and precautions

Medicines Healthcare Products Regulatory Agency

August 26
13:08 2020

Reminder for healthcare professionals:

  • isotretinoin has important risks (including teratogenicity) requiring specialist oversight and therefore must not be used outside of the authorised terms of use
  • isotretinoin should only be prescribed for the treatment of severe acne by or under the supervision of physicians with expertise in the use of systemic retinoids and a full understanding of the risks of isotretinoin therapy and monitoring requirements (including for signs of depression)
  • isotretinoin is a powerful teratogen associated with a high frequency of severe and life-threatening birth defects if there is exposure in utero; women of childbearing potential must be under a Pregnancy Prevention Programme
  • only use isotretinoin for severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) that are resistant to adequate courses of standard therapy with systemic antibacterials and topical therapies
  • counsel patients fully on the potential risks of isotretinoin, including what to do if they feel their mental health is affected or worsening
  • be vigilant for serious side effects such as sexual dysfunction in patients taking isotretinoin
  • report any suspected adverse drug reactions to retinoid medicines to the Yellow Card scheme

New national independent safety review

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 (see section on the Pregnancy Prevention Programme and the potential for psychiatric reactions and sexual dysfunction. Isotretinoin should therefore be prescribed only by a consultant dermatologist-led team.

The MHRA regularly reviews the safety of isotretinoin, as for all medicines, to ensure that the benefits of use in UK patients continue to outweigh the risks. Following concerns raised by patients and patient representatives about the nature and severity of some adverse effects, the Commission on Human Medicines (CHM) has endorsed an independent review of the available evidence by the Isotretinoin Expert Working Group.

The review aims to examine the available evidence for the possible risks of psychiatric adverse reactions and sexual dysfunction, including whether they can persist for some time after discontinuation, and to advise the CHM whether further action is needed to minimise or to raise awareness of these risks in the UK. The Expert Working Group may also consider that other aspects of the safety of isotretinoin need to be reviewed based on the available evidence.

While the review is ongoing, we remind healthcare professionals of the important risks and precautions to take when prescribing or dispensing isotretinoin.

Risks of psychiatric reactions and sexual dysfunction

Depression, anxiety, and psychotic symptoms have been reported in patients treated with isotretinoin. Very rarely, suicidal thoughts, or suicide attempts, and suicide have been reported.

Patients prescribed isotretinoin should be advised of what to do if they feel their mental health is affected or is worsening. Patients taking isotretinoin are also recommended to ask family and friends to help watch out for potential symptoms of psychiatric disorders. The patient information leaflet provided with isotretinoin medicines is a good basis for this discussion.

All patients taking isotretinoin should be monitored for signs of depression by their prescriber and referred for appropriate treatment if necessary. Particular care is needed in patients with a history or family history of depression. Any concerns about possible psychiatric symptoms should be discussed with the prescriber and treatment may be stopped. However, it is important to remember that psychiatric symptoms may not be fully alleviated after discontinuation and further psychiatric or psychological evaluation may be necessary. The Expert Working Group will consider whether further action is needed to minimise these risks and/or ensure awareness of these risks.

Isotretinoin has also been associated with reports of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido as well as vaginal dryness. The exact incidence of these adverse reactions is unknown but they are currently thought to be rare. The Expert Working Group review will also explore the risks of these reactions and other symptoms of sexual dysfunction, their possible persistence after treatment cessation, and the impact reported by affected patients.

Reminder of pregnancy prevention advice

Isotretinoin, as all oral retinoids, is a powerful teratogen associated with a high frequency of severe and life-threatening birth defects if there is exposure in utero. Isotretinoin is contraindicated in women of childbearing potential unless all the conditions of the Pregnancy Prevention Programme are met. Following a detailed review, in 2019 pregnancy prevention educational materials for healthcare professionals and women were revised and simplified.

See Guidance from the MHRA on key principles to achieve compliance with a pregnancy prevention programmes for medicines during the COVID-19 pandemic (updated 19 May 2020)

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.

Report to the Yellow Card scheme electronically using:

Article citation: Drug Safety Update volume 14, issue 1: August 2020: 5

Published 26 August 2020

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