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unpublished clinical trials submitted to regulatory agencies in 1989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 2005;3:14).
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and unpublished, cannot rule out a modest increase in the risk of suicidal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.” |
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