Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, how many people prescribed Roaccutane have reported depressive side effects in each year since 2010.

Reports of ‘suspected’ Adverse Drug Reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects suspected ADR reports from the whole of the United Kingdom in relation to all medicines and vaccines. Reporting to the Yellow Card Scheme is voluntary for healthcare professionals and members of the public. There is however also a legal obligation for pharmaceutical companies to report all serious ADRs for their products that they are aware of.

MHRA has received 138 UK spontaneous reports of depressive disorders, depressed mood or depressive symptoms suspected to be associated with isotretinoin between 1 January 2010 and 31 December 2016. A breakdown of the reports received by year is displayed in the table below. This data includes all reports for isotretinoin irrespective of the brand name, which in some cases will not have been provided by the reporter.

UK, spontaneous reports of depressive ADRs suspected to be associated with isotretinoin between 1 January 2010 and 31 December 2016

*Data extracted from MHRA’ s Yellow Card Database of spontaneous case reports received in the UK.

It is important to note that Yellow Card reports are not proof of a side effect occurring but only a suspicion by the reporter that the medicine may have caused the side effect. Yellow Card reports may therefore relate to true side effects of the medicine, or they may be due to coincidental illnesses that would have occurred in the absence of medicine.