Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what data his Department holds on the number of cases that have been recorded where patients have complained of side effects from the use of Roaccutane in each year since 2014.

Roaccutane is a brand name for the medicine isotretinoin which is authorised for the treatment of severe forms of acne. National data on the total number of patients who have experienced side effects after using isotretinoin is not available. The Yellow Card scheme operated by the Medicines and Healthcare products Regulatory Agency (MHRA) collects information on suspected side effects in the United Kingdom. Since 2014, between 87 and 135 reports of side effects suspected to be associated with the use of isotretinoin have been received each year.

It is estimated that approximately 35,000 individuals receive isotretinoin each year in the UK. Estimates of the exact number of people treated with isotretinoin is not available as the dose is individualised based on the patient’s weight and their response to the medicine.

The product information for all medicines, including isotretinoin, contains advice about possible side effects and how to report them. Healthcare professionals receive the MHRA’s Drug Safety Update which includes information about possible side effects and any action which needs to be taken. Since 2014, the Drug Safety Update has included a number of articles on isotretinoin, including reminders on important risks and precautions.

The terms of the ongoing review of the risk of psychiatric and sexual side effects for isotretinoin include consideration of whether regulatory action is needed to ensure awareness of the risks associated with this medicine.