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WASHINGTON -- The Food and Drug Administration issued a second public warning
Friday that adults who use antidepressants should be closely monitored for signs
of suicide, especially when they first start the pills or change a dose.
Much of the concern over suicide and antidepressants has centered on children
who use the drugs. The FDA last fall determined there is a real, but small,
increase in risk of suicidal behavior for children and ordered the labels of
all antidepressants to say so.
A year ago, the FDA issued a warning that adults, too, may be at increased
risk. The agency began reanalyzing hundreds of drug studies to try to determine
if that's the case, and told makers to add or strengthen suicide-related warnings
on labels in the meantime.
Since then, several new studies have been published in medical journals about
a possible connection. Citing them, the FDA issued a new public health advisory
reminding doctors and patients to watch closely for suicidal thinking or worsening
depression and seek medical care if it happens.
It's a difficult issue to sort because depression can lead to suicide and studies
show that antidepressants have helped many people recover. But there are concerns
that antidepressants may cause agitation, anxiety and hostility in a subset
of patients who may be unusually prone to rare side-effects. Also, psychiatrists
say there is a window period of risk just after pill use begins, before depression
is really alleviated but when some patients experience more energy, perhaps
enabling them to act on suicidal tendencies.
In addition to the advisory, the FDA also updated its Web site with a notice
about a higher-than-expected rate of suicide attempts in research with the nation's
newest antidepressant, Eli Lilly's Cymbalta. Those studies were in women trying
Cymbalta as an incontinence treatment; it was never approved for that use. The
FDA said when it approved Cymbalta last year that studies of depressed patients
showed no suicide link.