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Arguably the most important section of a manufacturer insert, let’s look at Postmarketing Experience. Why is this the most important? The CDC captured it perfectly when stating:
Typically Section 6.2, the Postmarketing Experience section of an insert includes adverse reactions that have been reported after a product goes to market. Unfortunately, there isn’t much transparency on the threshold of when a reported adverse reaction must be listed in this section, however the FDA does provide some guidance below.
The layout may differ from insert to insert, however most will look like the example below.
This Postmarketing Experience is from the Zoloft manufacturer insert. As you can see, it is organized by type of reaction within disorders.
Pro tip: take your time in this section. Many of the terms used are medical in nature and might not be commonly understood. For example, “angioedema” is swelling. The best thing to do is copy + paste straight from the insert into your preferred search engine to read the definitions of each reaction. Be sure to click the “images” tab in your search engine to see visual examples of the reaction. If you suspect you are experiencing a listed adverse reaction, you can also type the reaction in YouTube and watch videos of the reaction in action. For example, I did not understand what exactly Ataxia was until I watched a YouTube video of someone walking that was suffering from this reaction.
We’ll talk more about how reactions are reported later on. Next up, let’s look at Drug Interactions.