Isotretinoin

| 12 min read

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.

The British Association of Dermatologists has produced a very helpful information leaflet 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.

Isotretinoin Information Leaflet

What are the risks and side effects?

• Common risks of treatment include dryness of the skin, eyes and lips; nosebleeds; sun-sensitivity; muscle and joint aches; blurred vision or impaired night vision (which rarely can be permanent) and increased fats in the blood (hyperlipidamia).
• Rarer risks of treatment 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 pyogenic granulomas (painful vascular growths most commonly around the nails).
• This is not a complete list of all possible side effects and additional side effects that are not widely recognised at the present time may become apparent in the future.
• 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.

What else should I know before starting treatment?

• Acne may worsen once Isotretinoin has been started. Rarely this can lead to a severe flare of the acne resulting in scarring.
• You must not donate blood during treatment with isotretinoin and for at least one month afterwards.
• You should immediately stop taking the medication if you notice any visual disturbance or other neurological symptoms and inform Dr Lynch.
• As for any medication it is essential to read the information leaflet that comes within the packaging and contains a full list of all recognised side effects.

New MHRA regulations

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.

Mental health assessment

The MHRA has stated that all patients must complete the following screening questionnaires for mental health conditions at the time of starting treatment and at any follow up appointments.

PHQ-9 for depression GAD-2 for anxiety

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.

Pregnancy prevention program

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:-

• Group A - I confirm I do not require contraception because there is no risk of pregnancy during treatment and for 1 month after treatment. I do not require pregnancy testing. I will let my prescriber know if my situation changes. Initial prescription will be for 4 weeks, subsequent prescriptions can be for up to 12 weeks.
• Group B - I confirm I have been using the contraceptive implant or have had a coil (IUD) or intra-uterine system (IUS) for at least 4 weeks. I agree to pregnancy testing at follow-up appointments. I may choose to do monthly pregnancy tests at home because no contraception is 100% effective. I will let my prescriber know if my situation changes. Initial prescription will be for 4 weeks, subsequent prescriptions can be for up to 12 weeks.  
• Group C - I confirm I have been using a hormonal contraceptive pill or contraceptive injection plus I agree to use a barrier method (i.e. a condom, female condom, vaginal cap). I agree to pregnancy testing every 30 days during treatment. My prescriptions will be for 30 days. Prescriptions will need to be collected within 7 days.

Females in Group C will need to attend every 4 weeks for a pregnancy test before a prescription can be issued.

Consent Form

The MHRA has made it a legal requirement that all patients undergoing treatment with isotretinoin read and complete the following consent form prior to starting treatment:-

MHRA Consent Form

Follow up appointments

The MHRA has stated that 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. Prescriptions for isotretinoin can be for no longer than 12 weeks.

You will be charged a fee whenever you attend for a follow up appointment. In some cases this appointment can be conducted remotely (for example over the telephone), however a fee will still be charged.

If you have medical insurance the cost of initial and follow up appointments may be covered, however you should check this carefully as not all insurance companies will cover the cost of acne treatments or follow up appointments.

Blood tests

You will need blood tests (a minimum of one blood test prior to treatment and one blood test whilst taking isotretinoin - usually after 1 month). You must not take isotretinoin without completing the advised blood tests or being informed of the results as you are at risk of serious or life-threatening side effects.

If you have medical insurance, your insurance provider may cover some or all of the cost of blood tests. You should check this carefully to ensure that you are not charged a fee by the hospital.

You can also ask your GP if they would be willing to perform the blood tests for you. Many GPs are willing to do this when asked, however they are not obliged to do so for patients receiving private treatment.

Pregnancy tests

All females with childbearing potential must perform a pregnancy test at the time that a prescription for isotretinoin is issued. If you perform this in a clinic or private hospital then you will be charged a fee for this. An alternative is to perform the test at home and bring a photograph of the result.

How much does treatment cost?

The costs of treatment are as follows:-

• New consultation: £250
• Followup consultation: £220 (each time you attend)
• Cost of medication: This is charged to you directly by the pharmacy that you take the prescription to. GPs cannot issue this prescription and as this is a private prescription, you are charged the full cost of the medicine by the pharmacy. Prices vary significantly from one pharmacy to another but on average you might expect to pay £20-40 for each month of medication.
• Blood tests (see above)
• Pregnancy test (see above)

Summary

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:-

1. Attend for a consultation so that I can assess your skin and discuss treatment options.
2. Read the British Association of Dermatologist's Patient information leaflet
3. Complete the PHQ-9 and GAD-2 screening tools for depression and anxiety and if there is evidence of these conditions then attend for a consultation with a psychiatrist prior to starting treatment.
4. If you have child bearing potential, inform me if you are in Group A, B or C with regards to the pregnancy prevention program (see above).
5. Read and sign the MHRA Isotretion Consent Form.
6. Attend for baseline blood tests: Full blood count (FBC), urea and elecrolytes (U&E), liver function (LFT) and cholesterol and triglycerides (Lipids).
7. If you are female you will need to perform a pregnancy test on the day that the medication is prescribed.

Frequently asked questions