In October 2023 the Medicines & Healthcare products Regulatory Agency (MHRA) introduced significant new regulations governing the prescription of isotretinoin. This has important implications for patients with mental health issues and for patients with the potential to become pregnant. These rules apply to all doctors prescribing isotretinoin and may mean that you need to attend for more appointments than previously or that you need to have a mental health assessment prior to starting treatment.
Isotretinoin, also known as Roaccutane or Accutane, is an oral retinoid. It is one of the most effective treatment for acne with approximately 85-90% of patients seeing a long term improvement in the skin after completing a course of treatment. Despite the potential side effects listed below, in my experience, the vast majority of patients tolerate treatment well.
Isotretinoin is taken as a course of treatment with the total amount required to complete the course determined by your body weight. The average duration of treatment is typically 6-9 months. You will start with a relatively low dose since there can be a temporary flare in your acne at the beginning of treatment and to allow you to get used to any side effects. After the first month or so the dose is typically increased.
Common side effects include dryness of the skin, eyes and lips; nosebleeds; sun-sensitivity; muscle and joint aches; impaired night vision and increased fats in the blood (hyperlipidamia). Rarer side effects include inflammation of the liver (hepatitis) or pancreas (pancreatitis); raised pressure within the brain; sexual side effects (which rarely can persist after stopping treatment); inflammatory bowel disease and a flare of acne resulting in scarring. Isotretinoin can cause mood disturbance and depression and has rarely been associated with suicide and it is essential to stop taking the medication and contact a doctor urgently if low mood arises.
The British association of Dermatologists has produced a very helpful Patient Information Leaflet that lists some additional rare side effects that may occur and provides additional information relating to treatment with isotretinoin and it is very important that you have read this and discussed any questions before starting the medication. As for any medication it is also essential to read the information that comes within the packaging and contains a full list of all recognised side effects.
All patients must complete the following screening questionnaires for mental health conditions:
If you have previously suffered from anxiety/depression or if the screening tools above identify evidence of depression or anxiety then it is important that you are assessed by a psychiatrist before starting Isotretion to determine whether it is safe for you to take this medication.
Isotretinoin causes serious birth defects and it is critical not to take the medicine if pregnant or breast feeding or for at least a month after. The MHRA mandates that patients with child bearing potential are enrolled in a pregnancy prevention program. Previously patients were allowed to take responsibility for not becoming pregnant and opt out of this program however this is now no longer permitted.
The MHRA states the following: "A person has childbearing potential if they have a uterus and at least one ovary unless they: (a) Have undergone surgical sterilisation (tubal ligation), confirmed by a healthcare professional. (b) Are post-menopausal, confirmed by a healthcare professional."
For patients with child bearing potential the MHRA has defined 3 groups of patients and this determines how often you need to attend for follow up:-
Females in Group C will need to attend every 4 weeks for a pregnancy test before a prescription can be issued.
All patients (male or female) will need to attend for a follow up appointment after the first month. Males and females with no reproductive potential or falling into MHRA Groups A and B can then attend every 12 weeks. Females falling into group C will need to attend every 4 weeks.
There is now very strict regulation governing the prescribing of Isotretinoin and if you would like me to prescribe then the following steps will need to be completed. These can be completed during your initial consultation:-