Adults taking the antidepressant Paxil (also known as Seroxat or paroxetine) should be monitored closely because the drug may increase the risk of suicide attempts, Norwegian investigators conclude after analyzing data primarily from unpublished studies.

The drug-maker, GlaxoSmithKline Plc, however, calls the results “flawed and misleading.”

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 British Medical Journal, 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 Selective Serotonin Reuptake Inhibitors (SSRI’S) 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: BMC Medicine, August 21, 2005.
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Also read this article: Glaxo says Paxil suicide study flawed, misleading