Medicines Healthcare Products Regulatory Agency
Following an in-depth expert safety review of the acne drug isotretinoin (commonly known by brand names Roaccutane and Reticutan), the Commission on Human Medicines (CHM) has agreed to a number of recommendations to strengthen the safe use of the treatment.
This includes recommendations to have tighter controls on use of the medicine in people under 18 to ensure it is only used for severe acne when other standard treatments have been sufficiently tried and not worked; improved information for patients so that they can make better informed decisions about their treatment; and consistent monitoring for potential mental health and sexual side effects in all patients throughout treatment.
Isotretinoin is used to treat severe forms of acne, especially if there is a risk of permanent scarring. This medicine is an extremely effective last-line treatment for severe acne. However, patients and members of the public have raised concerns about suspected side effects associated with isotretinoin, including psychiatric (mental health) and sexual side effects that sometimes continue after treatment with isotretinoin has been stopped.
In light of these concerns, the independent CHM formed the Isotretinoin Expert Working Group and asked it to look at the overall safety of the medicine. The expert review considered all the available evidence, including information from patients and their families, and concluded that the gaps in the available evidence meant that it was not possible to say that isotretinoin definitely caused many of the short-term or long-term psychiatric and sexual side effects. However, the individual experiences of patients and families continue to cause concern and the Group emphasised the need to ensure patients are made aware of all risks before starting isotretinoin treatment, for there to be greater oversight of prescribing in young patients under 18 and for patients to be monitored more regularly for side effects.
The expert review sets out a number of recommended actions to support the safe use of isotretinoin as an effective treatment for severe forms of acne whilst mitigating the possible risks. These have been endorsed by the CHM and will be taken forward by the MHRA.
Key recommendations are summarised as follows:
1. Better information - patients and their families should receive better information about the risks of isotretinoin so that they can make an informed decision before using this medicine.
2. Better monitoring - there should be consistent monitoring of a patients psychiatric and sexual health so that any problems are spotted earlier and there are defined routes for patients to receive help.
3. Better checks - there should be tighter controls on first prescribing isotretinoin to young people (aged 12 to 18) so that it is only started when doctors agree the acne is severe enough to justify it and that other standard treatments have been sufficiently tried and havent worked.
4. Better communication - patients should receive information about the risks of isotretinoin earlier, before they have a full discussion with a specialist dermatologist (an acne specialist). Patients and their families will then have more time to fully consider the benefits and risks of isotretinoin. All healthcare professionals involved in the care of patients should keep each other informed about any suspected side effects they become aware of in a particular patient.
5. Better knowledge - more research should be carried out into the risks of psychiatric and sexual side effects associated with isotretinoin. This includes the need for safety studies to gather more information about what happens to patients who take isotretinoin, for example a database (registry) to record possible side effects and other information during and after treatment.
Dr Alison Cave, MHRA Chief Safety Officer, said:
Uncontrolled and severe acne can have a significant impact on a patients mental wellbeing and can lead to permanent scarring. For these individuals, isotretinoin may be the only effective treatment option.
No medicine is completely free of risk and the conclusion of the independent Commission on Human Medicines is that on balance the benefits of isotretinoin for severe acne continue to outweigh the risks, but action should be taken to make sure patients are better aware of them, that they are carefully monitored throughout treatment, and that for patients under the age of 18 there is additional scrutiny on isotretinoin prescribing.
We are grateful for the continued involvement of patients, their families, and other stakeholders whose experiences and stories were vital in informing this patient-focused expert review and in developing its recommendations. We are now working to implement them with advice from the Implementation Advisory Group.
The MHRA is working with patients and other stakeholders including clinical organisations to implement the recommendations of the expert review. The CHM has formed an Implementation Advisory Group to advise on how best to introduce the new measures into clinical practice. The regulator will provide further communications and guidance in due course.
See the Drug Safety Update and the CHM Report