- 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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