FDA Alert Covers Cymbalta

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 use.”

The FDA Alert is posted at<www.fda.gov/cder/drug/infopage/duloxetine/default.htm>.