§ Ann ClwydTo ask the Secretary of State for Health (1) if he will list the drug manufacturers which have submitted studies to the comprehensive review of selective serotonin reuptake inhibitors being undertaken by the Medicines and Healthcare Regulations Agency; and how many of the studies each manufacturer submitted are(a) published and (b) unpublished; [176934]
(2) how many (a) published studies and (b) unpublished studies have been submitted by drug manufacturers to the comprehensive review of selective serotonin reuptake inhibitors being undertaken by the Medicines and Healthcare Regulations Agency; [176935]
(3) which (a) drugs and (b) drug manufacturers are the subject of the comprehensive review of selective serotonin reuptake inhibitors being undertaken by the Medicines and Healthcare Regulations Agency; [176936]
(4) when the comprehensive review of selective serotonin reuptake inhibitors being undertaken by the Medicines and Healthcare Regulations Agency will be published. [176940]
§ Dr. LadymanGlaxoSmithKline, Eli Lilly and Co Ltd., Solvay Healthcare Ltd., Wyeth Pharmaceuticals, Organon Laboratories Ltd., Lundbeck Ltd. and Pfizer Ltd. have submitted information to the Medicines and Healthcare Products Regulatory Agency (MHRA) for review by the committee on safety of medicines' expert working group on selective serotonin reuptake inhibitors (SSRIs).
The information submitted is in the form of study reports, analyses of studies and data from spontaneous reporting schemes. The following table provides the drug substance names and the number of placebo-controlled studies represented in the submissions on use in children and adolescents for each drug substance.
904W
Drug substance (product) Number of placebo-controlled studies submitted (paediatric
use, any indication)
Paroxetine (Seroxat) 6 Fluoxetine (Prozac) 4 Fluvoxamine (Faverin) 2 Venlafaxine (Efexor) 4 Mirtazapine (Zispin) 2
Drug substance (product) Number of placebo-controlled studies submitted (paediatric
use, any indication)
Citalopram (Cipramil) 2 Escitalopram (Cipralex) 0 Sertraline (Lustral) 3 The expert working group has completed its review of SSRIs in the treatment of major depressive disorder in children and adolescents and has published previously unpublished summaries of the trials on which its advice was based. The review of SSRIs in adults is on-going and further data are expected for most substances. To date the MHRA has received reports of 214 studies conducted in adult patients and 94 studies conducted in healthy volunteers involving paroxetine. It is not possible to identify from the data submitted which of the studies have been published in the scientific literature.
The expert working group expects to publish its report later this year.