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New Study Says Drug Labels for Children’s Medication are Inadequate


According to a new study from the U.S. Food and Drug Administration, only half of drug labels include adequate information on the safety, effectiveness, and dosage for children.  Overall, researchers found that 54% of all drug labels did not include useful pediatric information.  When only considering medication that is relevant to use in children, a surprising 44% of drug labels did not include child-related information.  Surprisingly (as well as sadly), these alarming statistics actually show an improvement over the past few decades.  In 1975, a study revealed that just one in five drug labels contained pediatric information.  Although progress has been made, the medical industry still has a huge problem with newborns, with a staggering 90% of the medications used to treat newborns not having been sufficiently tested for safety, efficacy, and dosing.

Lack of evidence” is said to be blamed for the insufficient labeling information.  The scarce data leaves much room for error.  When conducting drug studies, the number of children available with specific diseases is often less than adults.  Additionally, drug makers are less inclined to study drugs in children because of financial concerns (i.e., newborns and pediatric patients are smaller target markets and less likely to have prescription drug coverage and health insurance than Baby Boomers).

Recent legislation, however, has helped to increase the volume of pediatric drug testing.  In 1997, the Best Pharmaceuticals for Children Act was passed, allowing the FDA to provide financial incentives to drug manufacturers who conduct clinical trials on children.  The Pediatric Research Equity Act, enacted in 2003, requires pharmaceutical companies to evaluate the safety and performance of certain drugs in kids.  Since these laws have been passed, over 400 drug labels have been modified to include proper information regarding use of the drugs in newborns and children.

In the medical industry, there is an understanding that children are not mini-adults.  Children may react to drugs differently.  Their bodies may also metabolize drugs differently, and the actual underlying diseases that the drugs are meant to treat may affect their bodies in different ways than seen in older patients.  Often, healthcare providers are given little information and do little more than adjust the dose of medications for a lower body weight, with any evaluation of other risks that might be present in newborn or pediatric patients.

Here are some resources for patients who want to do further research before allowing their children to take medications:

Pediatric Drug Dosage Information from University Hospitals

Medication Safety – Safe Dosing

Pharmacology and Childhood Medications

FDA Resources for Parents on Pediatric Medications

For example, acetaminophen is a drug found in over 600 medicines that is commonly used to reduce fever and relieve pain.  Liquid acetaminophen comes in the form of concentrated drops for infants.  If a parent figures gives a larger dose of this to an older child, it could be a deadly mistake.  Concentrated drops in much larger amounts—a teaspoon for example—can cause fatal overdoses.  Parents can often give inadvertent overdoses of these medications since they are commonly contained in a number of cough and cold medications and other over-the-counter drugs that might be given together.


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