Study Finds Age Recommendations Unclear for Infants

It’s not uncommon for parents and caregivers to administer over-the-counter (OTC) medications to children, including infants. To determine if your child is old enough to consume a certain drug, refer to the warnings on the label. For instance, cold and cough medicines aren’t recommended for children under the age of four.

However, a new study published by researchers at the University of North Carolina at Chapel Hill published in JAMA Pediatrics finds that when it comes to newborns, labels aren’t providing enough information.

The focus was primarily on neonates (infants up to 28 days old). There are very few drug tests in neonates, according to the study, and determining effects medicines have on this age group can be difficult if relying on studies involving older age groups.

The problem is that not all medications are clear when it comes to identifying if they’re appropriate for use in newborns. So there is the risk of administering a potentially harmful drug to a baby in this age group.

Labeling Requirements for OTC Medications

The U.S. Food and Drug Administration (FDA) requires the following information be printed on all OTC drug product labels: 

  • the title “Drug Facts”;
  • active ingredients;
  • purposes;
  • uses;
  • warnings;
  • directions; and
  • inactive ingredients. 

The FDA also recently permitted generic drug manufacturers to make changes to safety labels, which could leave these manufacturers open to liability. They also require this information to be located on the wrapper of the package or the outside container. If there are different dosages based on age groups, those should be indicated in a table format.

For instance, it may indicate that adults and children 12 years of age and older take two tablets every six hours. For children six to 12 years old: take one tablet every six hours. For children under six years of age, consult with a physician.

When a drug label’s information is insufficient or incorrect and it leads to illness, it might be possible to file a claim against the manufacturer. An attorney can help determine your rights and legal options if you find yourself in this situation then call Gacovino, Lake & Associates at 800-550-0000.

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