Back to: How to Read an Insert Training Course

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For specific manufacturer guidance, be sure to read this section (typically Section 8). Per the FDA, here is the information covered in this section:

For an example, let’s look at Lipitor’s Use in Specific Populations section for pregnancy.

Based on manufacturer guidance, Lipitor should be discontinued as soon as pregnancy is recognized and may cause fetal harm.

Here’s an example of this section concerning nursing mothers + Valium:

And below, the manufacturer for Clomid states this concern:

Our last example for this section comes from the manufacturer for Synagis:

Wondering how this section is populated? Most manufacturers do not include special populations like pregnancy in clinical trials. There might be supplemental studies after a product has gone to market or the manufacturer might have an ongoing registry of patients in special populations after it is available to the public. For example, the HPV vaccine manufacturer has a pregnancy exposure registry (see below) in the insert:

The next section might not be in every insert, but we’ll cover it in case the insert you’re reading does include a drug abuse + overdose section.