The Isotretinoin Expert Working Group of the Commission on Human Medicines (CHM) of the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has developed recommendations to strengthen the safe use of isotretinoin. The recommendations include new warnings, the need for continuous monitoring of psychiatric adverse effects, the introduction of new requirements for monitoring adverse effects related to sexual behavior, and additional supervision of the start of treatment in patients younger than 18 years.
Summary
The CHM Isotretinoin Expert Working Group has provided recommendations for strengthening the safety of isotretinoin use. The recommendations include new warnings, the need for ongoing monitoring of psychiatric adverse effects, the introduction of new requirements for monitoring adverse effects related to sexual behavior, and additional supervision of the start of treatment in patients younger than 18 years.
While processes are being developed to support the implementation of these recommendations in the healthcare system, physicians who prescribe isotretinoin are reminded of the need to inform all patients in detail about the potential benefits and risks associated with the use of isotretinoin, as well as the need for careful monitoring of patients to detect any adverse reactions throughout the entire course of treatment.
No new actions are currently required from health care professionals.
Information on safety review
- The CHM and the Isotretinoin Expert Working Group recommended new measures to strengthen the safe use of isotretinoin;
- the recommendations include adding new warnings about the risk of sexual dysfunction, including the possibility of its persistence after treatment discontinuation, as well as advice to healthcare professionals to ask patients about symptoms or signs of sexual dysfunction before starting treatment with isotretinoin and to monitor patients for the development of new sexual disorders during treatment;
- the recommendations also include developing appropriate requirements for monitoring potential psychiatric adverse effects and introducing new requirements for monitoring adverse effects related to sexual behavior in all patients during treatment;
- before starting isotretinoin (isotretinoin) therapy in patients under 18 years of age, it is necessary that 2 prescribing specialists agree that the patient's acne is severe and that there is no other effective treatment;
- The CHM has formed an Implementation Advisory Group, consisting of experts and representatives of health care organizations, to provide advice on the implementation of these recommendations;
- there is currently no need for any new actions on the part of healthcare system professionals, but we urge physicians to discuss the risks comprehensively with patients who are considering the use of isotretinoin.
Recommendations for healthcare professionals
- isotretinoin (isotretinoin) is indicated for severe forms of acne (such as nodular or conglobate acne or acne with a risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterial medicinal products and topical therapy;
- continue to observe strict precautions when prescribing isotretinoin (isotretinoin), including the conditions of the Pregnancy Prevention Program (PPP);
- inform patients in detail about the potential risks along with the expected benefits before prescribing isotretinoin;
- assess the patient’s mental health before starting isotretinoin and conduct regular monitoring for the development or worsening of mental disorders;
- advise patients to seek consultation if they feel that their mental health or sexual function has been affected or is worsening. Patients with serious adverse reactions should be advised to discontinue treatment and seek urgent medical advice;
- report suspected adverse reactions associated with isotretinoin (isotretinoin).
Advice for patients and caregivers
- isotretinoin is effective in severe forms of acne, especially if there is a risk of permanent scarring, but, like any medicinal product, it is associated with a risk of adverse reactions;
- isotretinoin should be used only when other acne treatments have failed;
- not every patient experiences adverse reactions, but you should know about the risks and what to do if they occur – read the package leaflet that comes with the medicinal product to learn about the risks associated with the use of isotretinoin;
- consider the information from your doctor about the benefits and risks of using isotretinoin and decide whether isotretinoin is the right treatment for you
- adverse reactions associated with the use of isotretinoin should be reported.
Indications for the use of isotretinoin and potential risks
Isotretinoin is a medicinal product for the treatment of severe forms of acne. It should be prescribed only for severe forms of acne that do not respond to other treatments, such as antibacterial and topical medicinal products (creams or gels).
Isotretinoin has a number of important risks, including that it may cause serious harm to an unborn child if used during pregnancy. All patients taking isotretinoin must have blood tests to monitor abnormalities related to disorders of the hepatobiliary system and lipid metabolism.
Patients who used isotretinoin also reported suspected mental disorders and cases of sexual dysfunction, and these cases require immediate attention.
List of medicinal products containing isotretinoin and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 30.10.2023).
Holders of registration certificates for medicinal products containing isotretinoin, in accordance with the provided list, are to submit comments on the information published above.
To analyze the published information, the applicant must use the original text available at the following links:
