FDA bipolar screening requirement

In case you needed to see it and can’t find it in your own Prescribing Information (it’s a hunt), here’s the FDA-required paragraph that’s in every antidepressant package insert.



In case you can’t squint enough to make it out, it says, in the middle there, “patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.”

That, of course, is what the MoodCheck screening tool provides.