Isotretinoin: call for information to be considered as part of an expert review

Isotretinoin (Roaccutane, Reticutan, and Rizuderm) is a treatment for severe acne.

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting interested individuals including patients, patient representatives, healthcare professionals, researchers, and organisations to provide their views and any other information they consider relevant to support the review.

We are particularly interested in your views on the possible benefits and risks of isotretinoin treatment, the measures currently in place to minimise the risks and whether additional measures are needed to optimise its safe use.

All information provided through this call will be reviewed by the Isotretinoin Expert Working Group (IEWG), an independent group of medical and scientific experts, as well as lay representatives and observers from relevant clinical organisations. The IEWG will report to the Commission on Human Medicines who will review the final recommendations.

Once this review has been completed a report will be published on the MHRA’s webpage on GOV.UK and will also be sent to those who have indicated that they wish to receive notifications about the review. Details about the scope of the review and remit of the Isotretinoin Expert Working Group are available here. You may find this information helpful, if you have not already seen it.

To ensure that this review is comprehensive we are seeking your views, positive or negative, on four key questions and would be interested in receiving any other information you consider may be relevant.

Information sought

We are inviting your views on the following:

1. What is your view on the place of isotretinoin in the treatment of acne? We are interested in all views, both positive and negative.

2. What is your view of the risks associated with taking isotretinoin, particularly in relation to potential side effects such as psychiatric effects, including effects on mood or mental health and or sexual dysfunction including the ability to experience sexual pleasure?

3. What is your view on the measures currently in place to reduce the risks associated with isotretinoin?

4. In your opinion, what further measures could be taken to optimise the safe use of isotretinoin and raise awareness of the potential risks?

How to respond

Please provide your responses using our secure online form.

This form gives you the option to draft your answers within the form or to upload a supporting document for each question, if you wish to prepare these in advance. A variety of document formats are accepted. The maximum size of these documents is 16MB each.

All information submitted will be considered by the IEWG. If you have already submitted information for the IEWG to consider, you do not need to submit the same information again. However, we would welcome your responses to the four questions in the form.

If you or someone you know has experienced any psychiatric or sexual side effects which you suspect were related to the use of isotretinoin and you would like to provide further details, we recommend that this information is submitted to the Yellow Card scheme if you are based in the UK or to your national regulatory authority if you are outside of the UK.

Submitting a report to the Yellow Card scheme is the most secure way to provide this information and will ensure your experience is considered within this review and contributes to the ongoing monitoring of the safety of isotretinoin.

You may be interested in this short video to help explain how to submit a Yellow Card report. Please find additional details of the type of information to include in your Yellow Card report which will help support this review here.

We welcome any views or information you may wish to provide. We are particularly interested in the experience of patients in the UK but will also accept contributions from those living outside the UK.

Deadline

The call for contributions is due to close on 16 February 2021

Consideration by the IEWG

All information submitted will be considered by the IEWG as part of their review. The IEWG will then make their recommendations to the Commission on Human Medicines.

Following completion of this review a report of the IEWG’s conclusions and recommendations will be published on this website and also sent to those who have registered an interest indicating that they would like to receive notifications.

Keeping you updated

After you have completed the four questions you will be asked to provide contact details and asked to indicate whether you wish to receive notifications on the review.

We will only use these details to notify you about this review. As outlined in the MHRA’s Data Protection and Privacy Information, your information will not be used or shared in any other way.

Information on opportunities to further contribute to the review will be published on the review webpage as they arise and notifications will be sent to individuals who have indicated they wish to receive them.

Contact us

If you have any questions about your submission or are experiencing any problems please contact info@mhra.gov.uk