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Clinically significant adverse reactions or risks of the medical product will be listed under the Warnings and Precautions section. While incredibly important, this section is most likely populated from clinical trial data (more on that soon) which means it is data before the product went to market. Because of this, the estimates or rates provided might not paint an accurate picture. However, the manufacturer will list known risk factors and information on how to prevent, mitigate, or monitor adverse reactions or risks. If you plan to accept a product, be sure to read this section to expedite treatment if an adverse reaction occurs!
Let’s go back to our DTAP example. Here is a segment from the Warnings and Precautions section:
According to the manufacturer, if a child has had persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours of a previous DTAP injection, then this condition might increase the risk for a serious adverse reaction to another DTAP dose.
Make sure you read all contraindications, warnings, and precautions prior to accepting any medical product for you or your child. If your medical provider is unaware of them, be sure to print out the manufacturer insert and bring it to your appointment.