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US Product Labels: "Post Marketing" vs "Adverse Reactions"

A random question . . .

Does anyone know the history of the “Post Marketing” vs “Adverse Reactions” section in product labels? I see @jon_duke make reference to “Post Marketing” section in his work on SPLICER. But I’m not often seeing this section any more on US PLs on DailyMed. Were “Post Marketing” and “Adverse Reactions” sections combined or am I just missing labels where the “Post Marketing” section still exists?

@ericaVoss Ah the nostalgia…

Post Marketing was commonly a separate subsection of Adverse Reactions. For newer drugs, the section often does not appear because of limited post marketing data.

The main reason for separating is that some people felt there was a continuum of confidence regarding the “realness” of labeled AEs. And Post Marketing fell at the bottom (ie laundry list of events that were reported but not rigorously confirmed). Whether this is an accurate assertion or not is a separate topic. But it was handy to have the section clearly labeled.

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