Concerns over paroxetine suicide risk emerge again
Depressed adults taking SSRIs should be monitored for suicidal ideation
Increased suicidal activity observed in children and adolescents taking paroxetine may also be present in adults, warn researchers. But GlaxoSmithKline, manufacturer of Seroxat, claims the researchers' analysis is misleading since it focuses on incorrectly selected data collected 15 years ago.
Ivar Aursnes, University of Oslo, Norway, and colleagues analysed 16 unpublished clinical trials submitted to regulatory agencies in 1989 as part of a successful licensing application for Seroxat.
The trials included were double blind, parallel design studies of adults receiving paroxetine or placebo. The researchers compared suicide attempts among 916 patients treated with paroxetine and 550 patients given placebo taking the length of exposure to paroxetine into account.
In total there were seven suicide attempts among the paroxetine patients and one attempt among the placebo patients, the researchers say. They used a Bayesian approach to analyse the data and their results indicate that there is a high probability that paroxetine is associated with an increased “intensity per year” of a suicide attempt (0.90 at worst and 0.79 at best).
“The recommendation of restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately [PJ, 14 June 2003, p813] should include usage in adults,” the researchers conclude (BMC Medicine ).
In a press release, the Medicines and Healthcare products Regulatory Agency said: “The available clinical trial data, both published and unpublished, cannot rule out a modest increase in the risk of suicidal thoughts and self-harm for selective serotonin reuptake inhibitors compared with placebo. However, there is insufficient evidence from clinical trial data to conclude that there is any marked difference between members of the class of SSRIs, or between SSRIs and other antidepressants, with respect to their influence on suicidal behaviour.” All new evidence will be carefully reviewed and new advice issued as appropriate, it added.
GlaxoSmithKline pointed out that in 2005, the Committee for Medicinal Products for Human Use, 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. “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.”
Citation: Electronicjuice URI: 10020535
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