其 他 安 全 警 示
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| The United Kingdom: Isotretinoin (Roaccutane▼): reminder of important risks and precautions (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) reminds healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretinoin should be supervised by specialist dermatologists with a full understanding of the potential risks and monitoring requirements.
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. 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 United Kingdom 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 United Kingdom. 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, MHRA reminds 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.
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/isotretinoin-roaccutane-reminder-of-important-risks-and-precautions
In Hong Kong, there are 11 registered pharmaceutical products containing isotretinoin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to isotretinoin, and these cases are related to miscarriage, maternal exposure during pregnancy and ectopic pregnancy.
Related news was previously issued by Health Canada (for birth defects) and MHRA (for psychiatric side effects and sexual dysfunction), and was posted on the Drug Office website on 8 Sep 2016 and 27 Oct 2017. Letters to inform local healthcare professionals were issued by the DH on 27 Oct 2017.
Currently, it is a requirement that a patient information leaflet, in both Chinese and English, should be provided in each package of the products containing isotretinoin, highlighting the teratogenic effect. The package insert should include warnings about suicide and suicidal attempts. The package insert should also include safety information on sexual dysfunction including erectile dysfunction and decreased libido.
The DH will remain vigilant on safety update of the drug issued by MHRA and other overseas drug regulatory authorities.
Ends/Thursday, Aug 27, 2020
Issued at HKT 18:00
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