On October 18-19, 2007, two advisory committees of the U.S. Food and Drug Administration (FDA) gathered in Maryland to discuss the safety and efficacy of OTC cough and cold medicines for children. The panels, in a majority vote of 13-nine, voted to recommend to FDA that cough and cold active ingredients should no longer be available for use in children under six-years-old.
- This is only a recommendation and not a determination or action by FDA. FDA is currently reviewing this recommendation and all the data discussed during the advisory committee meeting to determine what actions, if any, it will take.
- If FDA were to adopt this recommendation, parents would be left with no over-the-counter medicinal relief when their children under age six suffer from cold symptoms.
- The data show that these medicines are safe when used as directed and that harm to this age group, while rare, is attributable in most cases to accidental ingestion, an issue of safekeeping that is best addressed through education.
- The medicine makers are continuing their education efforts, with the launch of a major multi-year educational campaign for parents and other caregivers, and healthcare professionals. The campaign stresses the safe use and safekeeping of OTC cough and cold medicines to prevent misuse or accidental ingestion.
- Tips are available to parents on how to safely give oral OTC cough and cold medicines to children.
Harm from OTC cough and cold medicines is rare and, when it does occur, is almost always the result of misuse (significant overdose or accidental swallowing due to medicine not being properly stored and secured).
- As with all medicines, dosing instructions for all over-the-counter remedies must be read and followed carefully. It is important to remember that any medicine can cause harm if taken or used improperly.
- If a parent or other caregiver has any questions about a child’s healthcare, they should always contact a healthcare professional for assistance.
- Safe use and safekeeping are extremely important. Giving medicine according to label directions is part of the solution; storing it out of the sight and reach of children is part of it, as well. More tips are available online.
The makers of medicines want to ensure that parents and caregivers understand when and how to use OTC cough and cold medicines safely.
The safe use of OTC medicines is our highest priority. Medicine makers will continue their long history of providing consumer education with the launch of a multi-year national educational program to build awareness among parents and other caregivers and healthcare professionals about how to safely use and store children's OTC cough and cold medicines, and, as importantly, when not to use them.