Does Paxil Cause Suicides?
August 24, 2005
Two articles
Paroxetine linked to higher rate of suicide attempts in adults
Adult patients taking the antidepressant drug paroxetine are at higher risk of attempting to commit suicide than those not taking medication.
A new analysis, published in BMC Medicine, of previous clinical data on paroxetine use adds the antidepressant to the list of Selective Serotonin Reuptake Inhibitors (SSRIs) that have been shown to increase suicidal tendencies in adult patients with depression.
Ivar Aursnes and colleagues from the University of Oslo, Norway, reanalysed data from 16 selected paroxetine trials. In the trials, patients diagnosed with depression had been randomly given either paroxetine or a placebo drug. Neither the participants nor the researchers conducting the initial studies knew what the participants had been given. Aursnes et al. did a new statistical analysis of the results of these studies, to evaluate the incidence of suicide attempts in both groups. In their analysis, they took into account the amount of time the participants had been exposed to paroxetine. Their results show that there were seven suicide attempts in the group on paroxetine, and only one among the patients on placebo.
Paroxetine has been shown to increase suicidal attempt rates in children and teenagers, but previous studies have failed to reach a conclusion as regards the effects of the drug on suicide attempt rates in adult patients. Gunnell et al., in the February 19th 2005 issue of the BMJ, warned doctors about an increased risk of suicidal behaviour in patients treated with SSRIs. Their conclusion was based on analyses of clinical data submitted by the pharmaceutical companies that produce SSRIs to the Medicine and Healthcare products Regulatory Agency. But Gunnell et al.'s study had not properly included data on paroxetine.
Aursnes et al. conclude that "the recommendation of restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults". They confirm that all SSRIs increase suicidal tendencies in depressed adults, "the data strongly suggest that the use of SSRIs are connected with increased intensity per year of suicidal attempts".
Source: Medical News Today, 23/08/2005
Drug company disputes claim of new study on antidepressant Paxil
Drug company GlaxoSmithKline (GSK) is disputing claims that its antidepressant Paxil was linked to an increased suicide risk in adults.
The study, published this week, by scientists in Norway, suggests the antidepressant was linked to an increased suicide risk in adults.
The drug manufacturer is arguing that the research was flawed and misleading.
This strongly worded statement, from Europe's biggest drugmaker, highlights industry sensitivity to drug safety issues, and comes after a Texas court awarded $253 million against Merck & Co. Inc. in a case over its painkiller Vioxx last week.
This is not the first time that GlaxoSmithKline's Paxil and other similar drugs have been linked to suicide and doctors around the world have been warned they should not generally be used among under-18s.
But now the researchers at Oslo University say that the drug also seemed to affect adults in the same way.
In their analysis of trials involving more than 1,500 patients they found seven suicide attempts among those taking the drug and only one among those taking a placebo.
According to GSK the analysis is misleading as it focuses on incorrectly selected data, collected 15 years ago when GSK was seeking approval for the medicine, which is also known as Seroxat and paroxetine.
The company says the study results only cause confusion and unnecessary concern for patients using an SSRI (selective serotonin reuptake inhibitor), such as paroxetine, for treatment of depression.
They say 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.
Earlier this year experts at the European Medicines Agency reaffirmed the positive benefit-risk for Paxil in the treatment of adult anxiety and depression.
The study is published in the BMC Medicine open access journal.
Source: News Medical Net, 23/08/2005