Most parents are unaware of the Food and Drug Administration’s (FDA) MedGuides; yet these FDA-approved information sheets are vital for informing parents about the potential for serious drug side effects and pediatric risks.
MedGuides are very different from the small package inserts that usually accompany a prescription drug. The normal prescription drug package inserts can be extremely lengthy, use medical terminology that is incomprehensible to the average consumer, and are normally printed with a very small font (4 point), which is difficult to read.
Conversely, MedGuides were specifically designed to be easier for the average consumer to read and understand. They must use a larger font (no smaller than 10 point), must be written using “nontechnical, understandable language,” and “shall not be promotional in tone or content.” They must describe “the particular serious and significant public health concern that has created the need for the Medication Guide” and must note any known “pediatric risks.”
Parents may also be unaware that per the Federal Code of Regulations, MedGuides must include “a statement of the risk, if there is one, of the patients developing dependence on the drug product.” Prescribed drugs that carry a risk of dependence include many ADHD drugs, anti-anxiety drugs and prescribed opioids, all of which are currently prescribed to children.
Knowledge is power. For parents, knowledge is also vital, particularly when it comes to being informed about pediatric drug risks. And while MedGuides do not contain every documented risk associated with a prescription drug (nor does every brand-name drug have a MedGuide), it is a starting point for parents faced with an emotional choice regarding these drugs and their children to educate themselves about any potential risk.