Black box risk
Last week's meeting of the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) to discuss antidepressants was a perfect example of the kinds of unintended consequences that occur when public discussion of a drug's side effects are separated from its benefits - and the discussion of side effects is separated from the negative consequences of the disease itself.
Unlike the general media, the committee and FDA considered all of the issues as a whole. The result was broad agreement over the facts, but inconclusive debate over how to include the facts in drug labels without further discouraging use beyond that which has already occurred as a result of media reports and previous additions of warnings to antidepressant labels.
Indeed, committee members and FDA agreed that there has been a sharp decline in use of antidepressants in the last few years since the first black box warning was added to the label of antidepressants in