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Restrictions on the sale of over-the-counter (OTC) cough and cold medications for children aged younger than 2 years and subsequent labeling changes in these products has led to a decline in their unintentional ingestion, therapeutic errors, health care facility referrals for ingestions, and serious medical outcomes in these children, a retrospective database study showed.
Restrictions on the sale of over-the-counter (OTC) cough and cold medications for children aged younger than 2 years and subsequent labeling changes in these products have led to a decline in their unintentional ingestion, therapeutic errors, health care facility referrals for ingestions, and serious medical outcomes in these children, a retrospective database study showed.
Ingestions of these medications also declined in 2- to 5-year olds, according to a comparison of OTC cough and cold medication ingestions reported to US poison centers between 2005 to 2006 (before restrictions and labeling changes were implemented) and 2009 to 2010 (after implementation). Initiatives in 2007 and 2008 to limit the use of OTC cough and cold medications in young children included the US Food and Drug Administration’s (FDA’s) advice not to use these drugs in children aged younger than 6 years; the Consumer Healthcare Products Association’s (CHPA’s) voluntary withdrawal of products marketed for use in children aged younger than 2 years; and CHPA warnings about use of these medications in children aged younger than 4 years.
Data comparisons of the preimplementation and postimplementation periods in children up to the age of 12 years showed that unintentional ingestions declined by 33.4% and therapeutic errors by 46.0% in all age groups. These declines were greatest in children aged younger than 2 years. Referrals to health care facilities for unintentional general ingestions also decreased 28.9% in children aged younger than 2 years between the preintervention and postintervention time periods. For children aged 2 to 5 years, the decrease was 19.9%. Health care facility utilization for therapeutic errors decreased 59.2% in children aged younger than 2 years while no significant change was seen in children aged from 2 to 12 years. Moderate and severe adverse outcomes for unintentional ingestions decreased by 32.4% in children aged younger than 2 years and by 21.3% in 2- to 5-year-olds (Mazer-Amirshahi M, et al. J Pediatr. 2013;163:1372-1376).
COMMENTARY These improvements are the result of hard work by pediatricians and other child advocates in mobilizing both the FDA and pharmaceutical companies as well as in educating parents in the office to avoid these ineffective, potentially harmful medications in young children. There is still work to be done, however. In a 2010 survey of caregivers for children aged younger than 2 years, 63% believed that cough and cold medications were effective in young children and 57% thought that these medications were safe. At the time of that survey, just 31% of caregivers were aware of the FDA guidelines for cough and cold medications (Pediatr Emerg Care. 2012;28:883-885). -Michael Burke, MD
MS FREEDMAN is a freelance medical editor and writer in New Jersey. DR BURKE, section editor for Journal Club, is chairman of the Department of Pediatrics at Saint Agnes Hospital, Baltimore, Maryland. He is a contributing editor for Contemporary Pediatrics. The editors have nothing to disclose in regard to affiliations with or financial interests in any organizations that may have an interest in any part of this article.