Paroxetine and suicidal behaviour
Oscar Burriel/Science Photo Library
 Paroxetine-treated young adults show increased suicidal behaviour |
GlaxoSmithKline has declared that suicidal behaviour in young adults, especially those with major depressive disorder, may be increased during treatment with paroxetine.
An analysis of placebo-controlled trials of adults with psychiatric disorders
found a higher frequency of suicidal behaviour in those aged 18–24
years treated with paroxetine than in those given placebo. The difference
was not statistically significant. Another analysis found a statistically
significant increase in the frequency of suicidal behaviour in patients
of all ages with major depressive disorder taking paroxetine, compared
with those given placebo.
“The finding of evidence of increased suicide attempts in adults
with major depressive disorder treated with paroxetine compared with
placebo
is new, and was not found in
… GSK’s prior analyses,” the company said. “Some
statements in the approved prescribing information will need to be amended
to reflect the results from this analysis,” it added.
Gordon Duff, chairman of the Commission on Human Medicines, has sent
a letter to health professionals about the findings.
“The new analyses highlight the importance of monitoring all patients
treated with selective serotonin reuptake inhibitors for worsening of
their symptoms or mood changes but do not alter the prescribing advice
for SSRIs issued in December 2004,” Professor Duff said in the
letter. This advice
was reported in The Journal at the time (PJ, 11
December 2004, p839).
GSK has published details of the analyses on its website (www.gsk.com). |