Back to: How to Read an Insert Training Course

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Unfortunately, this section is left bare in some manufacturer inserts. Nonclinical toxicology provides information on the propensity of the medicine to cause cancers in animals, for mutagenesis, effects of the medicine on animal fertility, and other animal toxicology/pharmacology findings

For the inserts that state a variation of the following phrase, “has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility,” it means the manufacturer has not evaluated if the product:

• is a cancer-causing substance or agent
• is capable of altering the genetic constitution of a cell by changing the structure of the hereditary material (DNA)
• or if it impairs the natural capability to produce offspring

Here’s an example of this section from an insert for an Epidural medication:

For any product that has a limited nonclinical toxicology section, it is recommended to keep tabs on your cancer risk.

We just covered all the sections of a manufacturer insert that are typically not provided to patients. However, the next lesson will cover a section of the insert that you might have been provided when prescribed a medical product.