According to the FDA, it is proposing drug companies to update their antidepressant product labeling to include warnings of increased suicidality, defined as “increased risks of suicidal thinking and behavior” in adults ages 18 to 24 during the first two months of treatment. On the other hand, data suggests that adults ages 65 and older have reduced suicidality with antidepressants. This proposal will affect the entire category of antidepressants, and that available information could not exclude a single medication from this increased suicidality risk.
Here’s what one of my (pharma industry) colleagues Steve thinks about the black box warning.
