A new study, "Cough and Cold Medication Adverse Events After Market Withdrawal and Labeling Revision," shows that emergency department visits associated with over-the-counter (OTC) pediatric cough cold medicines in children age 3 and younger have declined following voluntary industry labeling initiatives specifically designed to improve safe use in this age. Conducted by researchers at the Centers for Disease Control and Prevention (CDC) and published today in the journal "Pediatrics," the study notes that unsupervised ingestions - curious young children getting in to medicines that were left within reach - drove the vast majority of the few adverse events in young children.
Manufacturers voluntarily withdrew OTC infant cough and cold medications in 2007 to curtail unsupervised ingestions in this young population. A year later, in conversation with the Food and Drug Administration (FDA), manufacturers relabeled these products only for use in children age 4 and older and initiated ongoing educational efforts to reinforce age-appropriate safe use and safe storage.
"The data show what we know to be true: Education and proactive efforts to help parents appropriately use over-the-counter pediatric cough and cold medicines are working," said Barbara Kochanowski, Ph.D., vice president of scientific and regulatory affairs at the Consumer Healthcare Products Association (CHPA). "Through education and packaging and labeling improvements, manufacturers are helping parents choose the right medicine, use the right medicine, and store medicine appropriately to avoid accidental, unsupervised ingestion—the primary cause of the rare reported adverse events involving these medicines."
"Our industry is committed to ensuring the safe use and storage of these medicines," she continued. "The CDC study published today shows these industry initiatives to enhance the safety and safe use of these medicines have had an impact on both adverse drug reactions in infants and toddlers as well as accidental unsupervised ingestions. Already rare, there have been declines in both."
Education is the key to prevention. The CHPA Educational Foundation's "Treat with Care" campaign educates parents and caregivers on how to appropriately and safely use OTC cough and cold medicines in children, including not to use in children under age 4. The CHPA Educational Foundation partners with CDC, the PROTECT (Prevention of Overdoses & Treatment Errors in Children Taskforce) Initiative, FDA, and healthcare provider groups on Up and Away and Out of Sight - an award-winning national educational campaign to alert parents and caregivers about the importance of safe medicine storage and reduce the number of accidental unsupervised ingestions.
"Treat with Care" reminds parents and caregivers, when giving OTC medicines to children, to follow these important tips:
-
Always read and follow the label.
-
Do not use cough and cold medicines in children under the age of 4.
-
Never give an adult medicine to a child. Always follow the age and dosing instructions as specified on the medicine label and use the accompanying measuring device.
-
Only use the medicine that treats your child's specific symptoms.
-
Never give two medicines with any of the same active ingredients.
-
Never use cough, cold, or allergy medicines to sedate your child.
-
Put medicines up and away and out of sight - EVERY time you use them. Remind guests not to put medicines in purses, coats, or places children can get into.
-
Keep the Poison Help center phone number - (800) 222-1222 -handy in case of emergency.
-
Consult a doctor, pharmacist, or other healthcare provider with any questions.
Antiseizure medications in pregnancy tied to child neurodevelopment risks