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Written Question
Roaccutane: Side Effects
Thursday 26th January 2017

Asked by: Baroness Berger (Labour - Life peer)

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.

Answered by Baroness Blackwood of North Oxford

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

Year report received

Number of reports

2010

11

2011

8

2012

37

2013

26

2014

24

2015

22

2016

10

*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.

Select Committee
Professor Louis Appleby, Director of the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness, Professor Carmine Pariante, Professor of Biological Psychiatry, Institute of PsychiatryRt Hon Jeremy Hunt, Secretary of State for Health, Professor Kevin Fenton, Director of Health and Wellbeing, Public Health England, Jonathan Marron, Director of Community, Mental Health and 7 Day Services, Department of Health, Phoebe Robinson, Head of Mental Health and Secure Care, NHS England

Oral Evidence Nov. 29 2016

Inquiry: Suicide prevention inquiry
Inquiry Status: Closed
Committee: Health and Social Care Committee (Department: Department of Health and Social Care)

Found: The other side of that is that areas where the suicide rate is not high find it easier to pull back

Select Committee
Mr David Roberts
 SPR0096 - Suicide prevention inquiry

Written Evidence Oct. 13 2016

Inquiry: Suicide prevention inquiry
Inquiry Status: Closed
Committee: Health and Social Care Committee (Department: Department of Health and Social Care)

Found: Contents 1)Background 2)Introduction 3)Roaccutane (Isotretinoin) 4)Evidence 5)Conclusion 1) Background

Non-Departmental Publication (Transparency)
Medicines and Healthcare products Regulatory Agency

Jul. 20 2015

Source Page: Human Medicines Regulations 2012 Advisory Bodies annual report 2014
Document: Human Medicines Regulations 2012 Advisory Bodies annual report 2014 (PDF)

Found: a reduction in the dose and duration of treatment due to the increased risk of serious cardiac side

Non-Departmental Publication (News and Communications)
Medicines and Healthcare products Regulatory Agency

Dec. 19 2014

Source Page: Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders
Document: Public Assessment Report: Review of isotretinoin and psychiatric adverse reactions (PDF)

Found: Tell your doctor if you experience any side effects. 4 1.

Scottish Parliament Written Question
S1W-20961
Tuesday 25th December 2001

Asked by: Sturgeon, Nicola (Scottish National Party - Glasgow Southside)

Question

Answered by Chisholm, Malcolm

The Executive has not made any such representations and has no plans to do so.The Medicines Control Agency continuously monitors the safety of all medicines. If new side effects are detected, the product information is updated to ensure it contains all of the available information to aid the safe use of the medicine. The adverse reactions known to be associated with Roaccutane treatment are fully described in the product information, which consists of a Summary of Product Characteristic for healthcare professionals and a Patient Information Leaflet for patients.
Westminster Hall
Dermatology Funding - Wed 04 Dec 2013
Department of Health and Social Care

Mentions:
1: Caroline Nokes (CON - Romsey and Southampton North) Even dermatology drugs—drugs for the skin—can have severe side effects, including depression, and I am - Speech Link
2: Jamie Reed (LAB - Copeland) Members debated the side effects of a drug, Roaccutane, used to treat acne. - Speech Link

Westminster Hall
Roaccutane - Tue 03 Dec 2013
Department of Health and Social Care

Mentions:
1: Nick Harvey (LDEM - North Devon) Having heard of its “miraculous” effects, Jon began taking Roaccutane to clear a relatively mild case - Speech Link
2: Nick Harvey (LDEM - North Devon) Roaccutane is a vitamin A-related compound that has long been known to cause psychiatric side effects - Speech Link
3: Norman Lamb (LDEM - North Norfolk) However, all effective medicines are associated with a risk of side effects in some people. - Speech Link