MHRA isotretinoin guidance for under-18s — March 2024

The MHRA updated isotretinoin rules in March 2024. Now anyone under 18 needs approval from two healthcare professionals before treatment starts. The change aims to reduce risks tied to mood, behavior, and sexual health while keeping acne treatment available when needed.

What this means for patients and families

If you or your child are being considered for isotretinoin, expect more questions and checks. Prescribers must get informed consent, confirm you understand side effects, and agree a clear plan for monitoring. Expect conversations about mental health, sexual activity, and contraception. For anyone who can become pregnant, pregnancy prevention steps and regular pregnancy tests are enforced.

Don’t be surprised if a dermatologist or specialist asks a GP or another clinician to co-sign or confirm the treatment plan. That’s the second prescriber. It’s about extra safeguards, not blocking access.

Practical checklist — what to do and ask

Use this checklist at appointments so you leave with clarity:

• Ask who the two prescribers are and why both are involved.
• Confirm how often you’ll be checked for mood changes and side effects.
• If pregnancy is possible, ask about contraception options and the schedule for pregnancy tests.
• Get written information on common and rare side effects and what to do if they show up.
• Ask how to report side effects — in the UK you can use the MHRA Yellow Card scheme.

If you notice increased anxiety, depressive thoughts, or sexual problems, contact your prescriber right away. Keep a simple symptom diary — it helps clinicians spot patterns faster.

Clinicians should document consent, risk discussions, and the second prescriber’s review. Pharmacists may be asked to verify checks were done before dispensing. The goal is clear records and regular follow-up, not extra paperwork for its own sake.

Access to treatment might take a little longer while the extra checks happen. If delays cause concern, ask your clinic what interim measures (topical treatments, antibiotic courses, or supportive care) are appropriate until approval is complete.

Finally, if you want more official details or need to report a problem, visit the MHRA website and the Yellow Card reporting page. If you’re unsure what to do at any point, speak to your dermatologist, GP, or pharmacist — they can explain the process step by step and help arrange the second prescriber review.

March 2024’s rule is about making isotretinoin safer for young people. Ask questions, keep notes, and make sure follow-up plans are clear before starting treatment.