In conjunction with its release of the public health advisory regarding
increased risk of suicide in adults taking antidepressants, the FDA issued a
separate FDA Alert involving duloxetine (Cymbalta) and suicidality in
pediatric and adult patients.
The alert largely echoes the language of the advisory, noting that the FDA
is "highlighting that adults being treated with any type of
antidepressant medication, particularly those being treated for depression,
should be watched closely for worsening of depression and for increased
suicidal thinking or behavior."
However, the alert goes on to say that "a higher than expected rate
of suicide attempts was observed in the open-label extensions of controlled
studies of Cymbalta for stress urinary incontinence (SUI) in women. An
increased rate of suicidality was not seen in controlled trials of Cymbalta
for treatment of depression or diabetic neuropathic pain (the approved
indications for Cymbalta)."
Finally, the FDA Alert notes, "The FDA is evaluating additional data
to determine the relationship, if any, between suicidality and Cymbalta