Back to: How to Read an Insert Training Course

Click “play” below for optional audio.

Haga clic en “reproducir” a continuación para obtener audio opcional.

Yes, when a manufacturer has updated information or the FDA requires an additional warning, the manufacturer insert will be updated and made available to the public. Depending if you are reading an insert before or after you’ve accepted a product, you may need to find an archived (or past) manufacturer insert. This is common if you suspect you have experienced an adverse reaction to a product.

To find an archived insert, type the trade name plus “archived insert” into your preferred search engine. For this example, we’ll search for an archived insert for the MMR vaccine.

Click on the first link to view the FDA’s MMR product page.

If there are archived inserts for this product, click on the bullet with “Supporting Documents older than…” After a few seconds, you’ll be brought to an archive database (example below).

Find the package insert (not the patient package) to view the archived manufacturer insert.

Why is this important? Some manufacturers change formulas or alter administration/dosing instructions. If you have potentially suffered an adverse reaction from a product, it is important to find the manufacturer insert applicable for when you received the product. This is especially important if you plan to file an adverse reaction report (more later).

Now you know how to find an insert, let’s learn how to read it!