New SSRI inquiry to consider patient experiences
pharmafile | October 29, 2003 | News story | Sales and Marketing |
The Government has conceded to intense pressure to give patients input into a new inquiry on the safety of SSRI antidepressants.
The new inquiry has been launched two months after the collapse of a previous investigation after two members of the MCA's Committee on the Safety of Medicines expert group were revealed to have financial ties with GlaxoSmithKline, manufacturer of the SSRI Seroxat.
The investigation into SSRIs was sparked by safety fears about Seroxat and claims by patients that it is addictive and can cause serious withdrawal symptoms and even suicidal behaviour.
Two investigations by Panorama brought concerns about the drug into the open and put increasing pressure on GSK to alter the drug safety warnings.
GSK has repeatedly denied the drug is addictive, but admitted that the wording on patient information leaflets is misleading and will now be changed.
The MCA, now the Medicines and Healthcare Products Regulatory Agency (MHRA), has itself not escaped criticism, with mental health charity Mind and health consumer group Social Audit saying its safety reporting system has failed to protect the public's interest.
The charity said the MCA was "playing Russian roulette with people lives" and that the CSM's yellow card scheme for reporting adverse events was inadequate.
But the MHRA's new inquiry seeks to address criticisms that it does not listen to patient experiences when reviewing the safety of medicines, which Mind says can provide invaluable information about a drug's safety profile.
Prof Alasdair Breckenridge, Chairman of the MHRA, said while SSRIs had been under close review for five to six years, the inquiry would look far more intently at patients' concerns about withdrawal reactions and potential links to suicidal behaviour.
"It is important that we listen to the views and understand the experiences of patients who have taken these popular antidepressants, including Seroxat, so patient reports are going to form an important part in the assessment of the safety of SSRIs" he said.
He added that the product information for the drugs would also be reviewed and strengthened if necessary and that the review as a whole would be conducted in "an open and transparent manner and the findings made public".
As well as Seroxat, other SSRIs licensed in the UK are Wyeth's Efexor, Eli Lilly's Prozac, Lundbeck's Cipramil/Cipralex, Solvay's Faverin and Pfizer's Lustral.
Membership of the CSM's expert group:
Chairman
Prof Ian Weller
Professor of Genitourinary Medicine & Head of Department of Sexually Transmitted Diseases, Royal Free & University College London Medical School, Vice Chair of the Committee on Safety of Medicines
Members
Prof Deborah Ashby
Professor of Medical Statistics, London University
Richard Brook
Chief Executive, Mind
Dr Jonathan Chick
Alcohol Treatment Unit, Royal Edinburgh Hospital
Prof Klaus Ebmeier
Professor of Psychiatry, University of Edinburgh
Dr Elizabeth Mukaetova-Ladinsk
Senior Lecturer in Old Age Psychiatry, New University, Newcastle General Hospital
Eamonn Oierney
Member of the Royal College of Psychiatry's Committee for Patients and Carers
Dr Ross Taylor
Senior Lecturer in General Practice, University of Aberdeen, and General Medical Practitioner Principal, Grampian Health Board
