GlaxoSmithKline disagrees with the conclusion from the sub-analysis conducted by scientists based in Oslo. It serves only to cause confusion and unnecessary concern for patients using an SSRI (selective serotonin reuptake inhibitor), such as paroxetine, for treatment of depression, said a release from GSK.

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. 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.

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.

Recently, the researchers at the University of Oslo, has reported that GlaxoSmithKline’s Paxil antidepressant is linked to a higher risk of suicide attempts in adults, according to a review of 16 studies, which was published in BMC Medicine journal.

The review looked at adult patients in studies comparing the Glaxo medicine against a placebo. The researchers at the University of Oslo, found seven suicide attempts among those taking Paxil, compared with one among those taking a placebo.

In April, European health regulators warned that Paxil, Eli Lilly & Co.'s Prozac and other antidepressants shouldn't be used to treat children due to a risk of suicide.