Parliamentary Search

Written question asked by Paul Burstow (Liberal Democrat) on Monday, 29 March 2004, in the House of Commons. It was due for an answer on Wednesday, 21 April 2004. It was answered by Stephen Ladyman (Labour) on Wednesday, 21 April 2004 on behalf of the Department of Health.

Dept of Health

Question
To ask the Secretary of State for Health, pursuant to his Answer of 24th March, 419 c913W, on the Committee on Safety of Medicines, what information was assessed by the Medicines and Healthcare Products Regulatory Agency in 2002; pursuant to his Answer of 24th March, 419 c913W, on the Committee on Safety of Medicines, what changes were made to the product information on risperidone in 2002.
Answer

Mr. Burstow: To ask the Secretary of State for Health (1) pursuant to his answer of 24 March 2004, Official Report, column 913W, on the Committee on Safety of Medicines, what information was assessed by the Medicines and Healthcare Products Regulatory Agency in 2002; [165299] (2) pursuant to his answer of 24 March 2004, Official Report, column 913W, on the Committee on Safety of Medicines, what changes were made to the product information on risperidone in 2002. [165300] Dr. Ladyman: The information assessed by the Medicines and Healthcare products Regulatory Agency in 2002 relating to cerebrovascular events associated with risperidone comprised: a review of serious cerebrovascular events in four randomised placebo controlled trials in dementia; two open-label extension trials in dementia and non-dementia studies; an analysis of non-serious cerebrovascular events (for example, very transient or mild transient ischaemic attack symptoms) in dementia studies; a review of relevant spontaneously reported suspected adverse drug reaction from the marketing authorisation holder's pharmacovigilance database. A review of the scientific literature was performed but did not locate any relevant articles or case reports. The following warnings were added to the summary of product characteristics for risperidone: "Cerebrovascular accidents have been observed during treatment with risperidone". "Risperidal should be used with caution in patients with known cardiovascular disease including those associated with prolongation of the QT interval and the dose should be gradually titrated". Consequential changes to the side-effects section of the patient information leaflet were made to clearly describe various symptoms of stroke, with an instruction to seek medical attention should these occur.

Secondary information

Type
Written question
Reference
420 c550-1W; 165299;165300
Session
2003-04
Subjects
Dementia Drugs Prescription drugs Safety Side effects Strokes Risperidone
Link
View this Written question on www.publications.parliament.uk