Are Children Protected when Half of all Medication Labels Lack Complete Safety Information?

Last month the U.S. Food and Drug Administration (FDA) reiterated their assertion that giving children medications requires special care.  In their publication, “Kids Aren't Just Small Adults - Medicines, Children and the Care Every Child Deserves,” the FDA lists the steps parents and caregivers must take to ensure they are safely providing over-the-counter (OTC) medications to infants and children. 

These tips include finding the proper medication, evaluating the child, handling drugs properly, and getting the information needed to use it safely.  However, a new study explains that drug labeling deficiencies continue to pose challenges when treating children. 

Reuters reports this study from FDA researchers found that after an evaluation of more than 500 drug labels in 2009, just half had information on proper dosing and safety for children.  Dr. Eric Lavonas of the Rocky Mountain Poison and Drug Center in Denver explains that drugs frequently make it to the market with little research on how they should be used in children.  

According to an FDA report, Ibuprofen is one of those medications which had incomplete dosing information for infants, yet remained a popular treatment for children.  Although parents have used the OTC medication to reduce children’s fevers for a long time, only recently has it received dosing information for children under the age of two years old.  Researchers have now indicated safe dosages of the medication for children from six months to two years old. 

Although an improvement in the number of drugs carrying children’s dose and safety information has been seen since the FDA instituted a pediatric program, experts still agree far more needs to be done to ensure children have safe access to OTC medications.  

However, researchers point out that a number of challenges stand in the way of pediatric drug testing.  Most notably, pharmaceutical companies have little motivation to carry out these studies because they have usually not viewed children as a market that would prove profitable.  Drugs that have received adequate study in children include those that do have a large children’s market, including vaccines, cold and cough medicines, and some antibiotics. 

Furthermore, ethical issues exist during testing.  Children cannot actually give their consent to undergo testing because they do not have a full understanding of the potential risks and other considerations, complicating the process of finding study participants.  

Finally, carrying out these studies in children is simply more difficult.  Researchers need child-friendly equipment, environments, doctors, and medical techniques, increasing already high research costs.  Furthermore, even procedures which are relatively simple for adults, such as taking blood or getting a urine sample, can be difficult with children.    

A HealthDay article reports that the study, printed in the current issue of the Journal of the American Medical Association, said new legislation is needed to “increase pediatric clinical trials and improve labeling.”  Other ways to implement this research in medications is by offering more incentives for drug makers carrying out these pediatric trials.  

However these children’s safety studies are encouraged, though, experts agree that a change in attitude needs to accompany pediatric testing.  It is important to stop treating children like second-class citizens and start offering them the same medication safety assurances as adults.