-Caveat Lector-
New UK Labeling Warns Of
Antidepressant Suicide Risk
7-9-1
LONDON (Reuters) - Patients taking antidepressants
may be at increased risk of suicide in the early stages of
recovery, according to a revised drug label agreed by
drugmakers and the UK Medicines Control Agency,
manufacturer GlaxoSmithKline Plc said on Monday.
The company, which markets the selective serotonin
reuptake inhibitor (SSRI) Seroxat -- known as Paxil in the
United States -- said in a statement that SSRI
manufacturers had been working with the agency to
agree changes to the summary of product characteristics
and patient leaflet.
It denied the update was a reaction to the $6.4 million
awarded last month to the family of Donald Schell by a
U.S. jury which decided Paxil was largely to blame for the
behavior of Schell, who shot dead his wife, daughter and
nine- month-old granddaughter and then killed himself
after he was prescribed the drug. GSK reaffirmed it would
appeal against this verdict.
GSK said that the revised label -- issued two weeks ago
-- for Seroxat and other SSRIs referred to the risk of
suicide and recommended that patients should be closely
monitored during the first few weeks or more of treatment
as they may not get better immediately.
``The possibility of suicide is inherent in depression and
may persist until significant therapeutic effect is achieved,
and it is general clinical experience with all antidepressant
therapies that the risk of suicide may increase in the early
stages of recovery,'' the new label says.
Claims that SSRIs -- which include Prozac -- can trigger
violent or suicidal behavior have sparked scientific
controversy and legal claims for compensation. Last
month David Healey, director of the department of
psychosocial medicine in Bangor, North Wales, said his
studies showed that SSRIs can cause even healthy
volunteers to suffer dangerous reactions.
In its latest statement, GSK said: ``It is important to
realize
that...the possibility of a suicide attempt is inherent in
depression and may persist until significant therapeutic
effect is achieved.
``Controlled studies of the relationship between suicide
and Seroxat have not provided any evidence that Seroxat
causes suicide. On the contrary, these studies
demonstrate that Seroxat reduces newly emergent
suicidal thoughts and suicide attempts.''
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