WHAT PARENTS NEED TO KNOW
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.
The FDA’s Medication Guide program, which began in 1998 under the U.S. Code of Federal Regulations, was created to make consumer-oriented, FDA-approved information sheets available for any prescription drug that had side effects of a “serious and significant public health concern.”
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.
While the FDA requires Medication Guides be available to consumers through pharmacists when dispensing drugs, most parents are unaware that they can read these Medication Guides online, before a drug is prescribed to their child, in order to have an educated and informed conversation with their prescribing physician.
The Know More About Drugs Alliance believes every parent should be made aware of MedGuides in order to be fully informed of a drug’s risk before administering it to their child. This is particularly true given that many of the drugs prescribed to children merit a “significant health concern” by the FDA, thus requiring a MedGuide. For example, the MedGuide for a commonly prescribed antidepressant states the drug “may increase suicidal thoughts or actions in some children, teenagers, and young adults”; while another MedGuide states that a common ADHD drug can include side effects of “new psychotic symptoms (such as hearing voices, believing things that are not true…) or new manic symptoms.”
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.