Study: Cough-cold manufacturers' voluntary label change on pediatric products reduced ER admissions

BURLINGTON, Vt. — The voluntary action taken five years ago by manufacturers of cough and cold medicines — namely to no longer recommend the use of OTC cough-cold products in children under the age of 4 years unless directed to do so by a doctor — has worked, according to a study published Monday online by Pediatrics, the peer-reviewed journal of the American Academy of Pediatrics. 

After a voluntary market withdrawal and labeling revision, emergency room visits for adverse events associated with cough-cold medicines declined both among children younger than 2 years and between the ages of 2 years and 3 years relative to adverse event visits for all drugs.  

“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,” stated Barbara Kochanowski, VP scientific and regulatory affairs at the Consumer Healthcare products Association. “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,” Kochanowski 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.”

Among children ages 2 years and younger, ER visits for cough-cold medicines decreased from 4.1% of all visits before the market withdrawal to 2.4% of all visits afterward. Among children ages 2 years to 3 years, ER visits  decreased from 9.5% of all visits before the labeling revision announcement to 6.5% of all ADE visits afterward. 

Unsupervised ingestions accounted for 64.3% of children less than 2 years old who suffered from an adverse event associated with a cough-cold medicine. And 88.8% of visits involving children ages 2 years to 3 years reported to an ER with an adverse event after the labeling revision announcement.

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