BY OUR PHARMA CORRESPONDENT
25 August, 2005: In an attempt to defend its tarnished anti-depressant Seroxat, GlaxoSmithKline has vehemently denied the findings of a scientific paper written by researchers at Norway's University of Oslo and published in the BMC Medicine journal.
Seroxat contains paroxetine, a selective serotonin reuptake inhibitor (SSRI).
The new paper, which reviewed some 16 randomised and, for the large part, previously unpublished studies of the drug, concluded that `the data strongly suggest that the use of SSRIs is connected with an increased intensity of suicide attempts per year' and that `the recommendation of restrictions on the use of paroxetine for children and adolescents conveyed by regulatory agencies should be extended to include usage by adults'.
The data show that in 1,466 people, there were seven suicide attempts among the 916 people randomized to receive Seroxat, but just one among 550 placebo recipients.
Charges linking Seroxat to suicides have already been levelled at GSK, though largely in relation to its use in children and adolescents and/or during the process of treatment withdrawal. The Norwegian revelations portray the data in such a way as to account for the risk to adults as well as to take the exposure time of the patients `properly into account' by comparing intensities (rather than numbers) of suicide attempts per year in drug and placebo groups.
However, GSK branded the Norwegian findings `misleading' and serving `only to cause confusion and unnecessary concern for patients using an SSRI such as paroxetine for treatment of depression'.
The sub-analysis is misleading as it focuses on incorrectly selected data, collected 15 years ago, which formed part of the successful regulatory submission in 1989 for use of paroxetine to treat depression in adults. The sub analysis also fails to acknowledge the current body of data, which is significantly more extensive and which has been recently reviewed by EU authorities,the company said in a press statement.
In 2005, the Committee for Medicinal Products for Human Use (CHMP) having re-examined all existing safety and efficacy data for paroxetine, reaffirmed the positive benefit-risk for paroxetine’s use in the treatment of depression and anxiety disorders in adults.
Paroxetine along with other SSRIs, has substantially helped the treatment of depression and other psychiatric diseases. As is stated in the prescribing information for paroxetine, depression is associated with an increased risk of suicidal thoughts, self harm and suicide and it is general clinical experience with all antidepressant therapies that the risk of suicide may increase in the early stages of recovery. Patients and physicians should be alert about the need to monitor for the emergence of suicidal ideation/behaviour when treating depression, the release added.
BY OUR PHARMA CORRESPONDENT