Nov. 21 2019
Source Page: Drug Safety Update: monthly PDF newsletterFound: 2 Gabapentin (Neurontin): risk of severe respiratory depression page 4 Isotretinoin (Roaccutane
Nov. 21 2019
Source Page: Drug Safety Update: monthly PDF newsletterFound: At time of its approval, data on the effects of olaratumab were limited due to the small number of patients
Aug. 27 2019
Source Page: MHRA: requests under the Freedom of Information Act (FOIA)Found: reports - broken down into individual figures per childhood vaccines - a ssociated reported side
Aug. 27 2019
Source Page: MHRA: requests under the Freedom of Information Act (FOIA)Found: Not held (not our info/not collected) 15/190 Various questions relating to Roaccutane and adverse
Asked by: Paul Farrelly (Labour - Newcastle-under-Lyme)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential health risks and psychiatric side-effects of the drug Roaccutane.
Answered by Jackie Doyle-Price
As with all medicines in the United Kingdom, the Medicines and Healthcare products Regulatory Agency continuously monitors the safety of isotretinoin-containing medicines. This includes reports of suspected adverse drug reactions submitted by healthcare professionals, patients and carers through the Yellow Card scheme, as well as published and unpublished data. As new evidence on safety emerges it is carefully evaluated and, where appropriate, product information is updated and advice for prescribers and patients is issued.
Specific assessments of possible psychiatric side effects associated with isotretinoin were considered by an Expert Working Group of the Commission on Human Medicines in 2005 and 2014. In addition, the risk of neuropsychiatric disorders was evaluated in a European review which was completed in 2018. This review concluded that the warnings in the product information for medicines containing isotretinoin regarding possible psychiatric adverse effects reflected what was known.
Since 1998, warnings regarding the possible risk of developing depression and other psychiatric side effects have been included in the product information for Roaccutane and the generic versions of isotretinoin (the Summary of Product Characteristics for healthcare professionals and the patient information leaflet). The product information for isotretinoin warns that treatment may be associated with possible psychiatric side effects, that particular care needs to be taken in patients with a history of depression; and that all patients on isotretinoin should be monitored for signs of depression and referred for appropriate treatment if necessary. It also states that stopping isotretinoin may not lead to improvement and therefore further psychiatric or psychological evaluation may be necessary.
Mentions:
1: Ian Mearns (LAB - Gateshead) regional music centre and our Gateshead Millennium Bridge that connects us to that village on the north side - Speech Link
2: Bob Stewart (CON - Beckenham) Isotretinoin, also known as Accutane or Roaccutane, is a drug used to treat severe acne primarily in - Speech Link
3: Paul Sweeney (LAB - Glasgow North East) I hope we can help people as much as possible to avoid the worst effects of a social security system - Speech Link
Mentions:
1: Bob Stewart (CON - Beckenham) But its side effects were enduring. - Speech Link
2: Jackie Doyle-Price (CON - Thurrock) Because of the serious side effects associated with the drug, as outlined by my hon. - Speech Link
Mentions:
1: Jeremy Hunt (CON - South West Surrey) interventions to address complications after childbirth, which have been linked to crippling, life-changing side - Speech Link
2: Caroline Johnson (CON - Sleaford and North Hykeham) Sometimes, as more drugs are given to more people, rarer side effects will come through, and the improvements - Speech Link
3: Ed Davey (LDEM - Kingston and Surbiton) On behalf of my constituents whose families have suffered from the effects of Primodos, I thank the Secretary - Speech Link
Oct. 26 2017
Source Page: Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libidoFound: Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased
Oct. 26 2017
Source Page: Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libidoFound: Tell your doctor if you experience any side effects. 4 1.