Increased
risk of suicide attempts in adults taking
paroxetine
Increased
suicidalilty in children and adolescents
following antidepressants has been the centre of
debate for several years. Inclusion of
unpublished data to the analyses has suggested
unfavourable risk-benefit profiles for some of
the drugs in this population of subjects. So far
it has appeared that a similar increase in
suicidal activities does not exist in adult
patients treated with selective serotonin
reuptake inhibitors (SSRIs). Unpublished, and
previously unavailable, data for paroxetine have
been included in a recent analysis.
A pooled analysis was carried out on 16 double
blind, parallel design studies. The patients
(all adults) were randomised to either
paroxetine (916) or placebo (550) in trials
which lasted for 6 weeks, except one of 17 weeks
duration. Paroxetine treatment made up 190.7
patient-years and placebo 73.3 patient-years.
The number of suicides, suicide attempts and
suicidal ideation were recorded and corrected
for duration of medication and placebo
treatment. The Bayesian statistical approach was
based on the construction of probability
distributions that describe the initial
uncertainty (or prior distributions, before
collection of real data ).
There were 7 suicide attempts among the patients
on paroxetine and one among the patients on
placebo. The probability that treatment with
paroxetine was associated with an increased
likelihood of suicide attempts per year was 0.90
with the pessimistic prior, and 0.79 and 0.85
with the two other priors, slightly pessimistic
and slightly optimistic.
These data suggest that the use of SSRIs is
associated with an increased risk of suicide
attempts per year in adults. The restrictions on
the use of paroxetine for children and
adolescents recently recommended by regulatory
agencies should also be applied to adults. Aursnes
I, Tvete IF, Gaasemyr J, Natvig B. Suicide
attempts in clinical trials with paroxetine
randomised against placebo. BMC Med 2005,
3:14.