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Paxil
may raise suicide risk in adults
Last Updated: 2005-08-22 16:19:48 -0400 (Reuters Health)
By Karla Gale
NEW YORK (Reuters Health) - 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data primarily from unpublished studies.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."
In the journal BMC Medicine, Dr. Ivar Aursnes and his associates
at the University of Oslo analyzed clinical data "presented
to the world's drug regulatory agencies in 1989." They included
16 studies featuring a total of 916 patients treated with
Paxil and 550 with inactive "placebo". Most trials ran for
6 weeks, although one lasted for 17 weeks.
More suicide attempts were observed among patients treated
with Paxil than among those who given placebo. The authors
conclude that the use of selective serotonin reuptake inhibitors
(SSRI), the drug class that includes Paxil, Prozac and Zoloft
among others, is associated with "increased intensity per
year of suicidal attempts."
In an interview with Reuters Health, Aursnes acknowledged
that they cannot rule out the possibility that the differences
between groups were due to chance alone. However, he said,
"I think when our figures are added to observations in other
studies, together they are rather convincing that there is
increased rate of suicide attempts" with SSRIs.
He added, "If patients express suicidal ideation, I think
they should be given these drugs under controlled conditions
like in a hospital or in a family setting where they can be
looked after."
In general, he believes that antidepressants "are used too
extensively in patients today," and that future research should
include longer trial periods.
In a statement, GlaxoSmithKline said the analysis was misleading,
focusing on incorrectly selected data, collected 15 years
ago when the company was seeking approval for the drug.
"It serves only to cause confusion and unnecessary concern
for patients using an SSRI, such as paroxetine, for treatment
of depression," GlaxoSmithKline said. "The sub-analysis also
fails to acknowledge the current body of data, which is significantly
more extensive and which has been recently reviewed by EU
authorities."
SOURCE: BMC Medicine, August 21, 2005.
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