Following a review of new data supplied by GlaxoSmithKline (GSK), the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has decided to recommend that Seroxat should not be used for children and teenagers under 18 years suffering from major depression.
GSK supports the MHRA advice that patients in this age group being treated with Seroxat should not stop treatment without first consulting their doctor.
Dr. Alastair Benbow, Head of European Psychiatry for GSK, commented: "The decision by the MHRA is solely concerned with the treatment of children and teenagers under 18 years with Major Depressive Disorder. It is not related to the use of Seroxat by adults, where this treatment has proven effective and has helped millions of people around the world to lead fuller and more productive lives.”
Suicide is a well-recognised and all too often tragic outcome of depression, and is one of the most common causes of death among young people. Depression is the most important cause of suicide, suicidal ideation and suicide attempts. There is no compelling evidence that Seroxat causes suicide and indeed, the adult clinical trial database does not demonstrate that Seroxat causes suicide, suicidal thinking or suicide attempts, the Company claimed.
"In our paediatric trials, which included over 1,000 patients treated with paroxetine, not a single person committed suicide. However, in our paediatric trials for patients with depression we have seen a difference between Seroxat and placebo in terms of suicidal thinking or attempts, particularly in adolescents. While we believe that today's move will inevitably limit the choices available to doctors treating children and teenagers under 18 years with Major Depressive Disorder, and the conclusions we draw from the data differ, we recognise the MHRA's decision for UK paediatric patients and we will work with them to implement the changes as soon as possible, " Dr. Benbow said.