Safety measures introduced for isotretinoin prescribing in patients aged under 18 years

Safety measures have been implemented for the use of isotretinoin in patients aged 12–18 years with severe acne.

In a statement published on 31 October 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) said two independent prescribers must agree that the acne is severe enough and has not responded to adequate courses of standard therapy before prescribing takes place.

In addition, healthcare professionals must provide detailed counselling to patients and their families on the potential risks of isotretinoin — including psychiatric and sexual side effects — and provide sufficient time to consider the treatment.

All patients will require an in-person assessment of their mental and sexual health prior to initiation and will be monitored for side effects at each follow-up appointment.

Isotretinoin is an effective last-line treatment for severe forms of acne that have not responded to standard treatments, such as antibiotics and topical treatments.

However, there have been ongoing concerns from patients and members of the public about side effects associated with the drug, such as depression and erectile dysfunction, that sometimes continue after treatment with isotretinoin has been stopped.

In April 2023, the Commission on Human Medicines published a report following a safety review into the use of isotretinoin, which listed some recommendations, including the need for two prescribers to agree on its use for a patient.

The safety review concluded that the gaps in available evidence meant it was impossible to say if isotretinoin definitely caused short or long-term side effects, but it was agreed that the individual experiences of patients and families were still a cause for concern.

Commenting on the safety measures, Henrietta Hughes, patient safety commissioner for England, said: “I welcome the new measures from the MHRA to strengthen the safe use of isotretinoin, commonly known by brand names Roaccutane (Roche Products Ltd) and Reticutan (Ennogen Healthcare Ltd), and used to treat severe acne.

“This guidance follows a patient-focused independent expert review of suspected mental health and sexual side-effects.

“The new measures will help to keep patients who are prescribed the drug safe and reduce the occurrence of potential severe side effects,” she added.

Alison Cave, chief safety officer at the MHRA, said: “Like all medicines, isotretinoin may be associated with potential side effects.

“While not every patient will experience them, the new measures will ensure that patients are well informed, that they are carefully monitored throughout treatment, and that there is additional oversight on isotretinoin prescribing for patients [aged] under 18 [years].”