Asked by: Kate Green (Labour - Stretford and Urmston)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to help ensure that medical professionals inform patients of the possible side effects of Roaccutane.
Answered by Edward Argar - Shadow Secretary of State for Health and Social Care
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.
Asked by: Kate Green (Labour - Stretford and Urmston)
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.
Answered by Edward Argar - Shadow Secretary of State for Health and Social Care
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.
Mentions:
1: Rachael Maskell (LAB - York Central) want to raise the case of one of my constituents who experienced topical steroid withdrawal and the side - Speech Link
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1: Julian Lewis (CON - New Forest East) This is what she has to say about the effects of these unnecessary procedures:“Mesh has restricted my - Speech Link
2: Mike Penning (CON - Hemel Hempstead) the industry, the pharmas, know that they have to cover themselves because they might be sued.The side-effects - Speech Link
3: Allan Dorans (SNP - Ayr, Carrick and Cumnock) Members have spoken eloquently this afternoon on the devastating effects of vaginal mesh implants and - Speech Link
Jul. 28 2021
Source Page: I. Government response to the report of the Independent Medicines and Medical Devices Safety Review. Incl. annex. 99p. II.Independent Medicines and Medical Devices Safety (IMMDS) Review. Independent report of the Patient Reference Group [established by Traverse], February – June 2021 [The Patient Reference Group (PRG) was established by Traverse]. 97p.Found: Reflecting on how information moves much quicker following Covid - 19 and reported side effects, some
Jul. 21 2021
Source Page: The Independent Report of the Patient Reference Group: response to the IMMDS Review reportFound: Reflecting on how information moves much quicker following Covid - 19 and reported side effects, some
Jan. 15 2021
Source Page: NHS Discharge Medicines Service – Essential Service: Toolkit for pharmacy staff in community, primary and secondary careFound: A consultation with Mrs Singh found she was happy with the change and there were no side effects or
Aug. 26 2020
Source Page: Isotretinoin (Roaccutane▼): reminder of important risks and precautionsFound: Possible side effects 5. How to store Roaccutane 6.
Mentions:
1: Nadine Dorries (CON - Mid Bedfordshire) organ prolapse and stress urinary incontinence, which have been linked to crippling, life-changing side-effects.Baroness - Speech Link
2: Tanmanjeet Singh Dhesi (LAB - Slough) Although those campaigning for the truth about the side effects of Primodos, sodium valproate and pelvic - Speech Link
3: Caroline Nokes (CON - Romsey and Southampton North) She spoke of the pregnancy prevention programme, but there are drugs out there, such as Roaccutane, for - Speech Link
4: Nadine Dorries (CON - Mid Bedfordshire) Friend has spoken about Roaccutane several times in the House. - Speech Link
Jul. 08 2020
Source Page: First do no harm: the report of the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Cumberlege. Incl. appendices. 269p.Found: effects.