In January 2008, the U.S. FDA issued a public health advisory warning parents of children under 2 years old to avoid the use of OTC cold and cough medicines (CCMs) because of concerns about "serious and life-threatening side effects." (That advisory is no longer available on the FDA's website.)
Then, in July 2015, the FDA targeted prescription CCMs, issuing a safety announcement regarding the potential risk of using codeine-containing cough suppressants in children. Subsequently, at an FDA expert roundtable meeting, participants indicated that cough should not be suppressed unless it is causing clinical consequences, such as poor sleep and/or vomiting, rib fractures, or hypoxia.
This meeting was followed in January 2018 by another announcement stating that the FDA is "requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18."
The FDA also reported that following the willing recall of OTC CCMs for those under age 2 years, manufacturers voluntarily relabeled these products to indicate that they should not be used in children under age 4 years. Further, the American Academy of Pediatrics has also stated that children aged 4 to 6 years should only use OTC CCMs upon the approval of their physician.
The authors of the JACEP Open article describe the role of dextromethorphan, antihistamines, herbal remedies (i.e., Echinacea purpurea, Pelargonium sidoides), vapor rubs, honey, prescription medications (i.e., codeine, promethazine, benzonatate, and inhaled corticosteroids) from an efficacy, safety, and abuse-potential perspective.
This review also addresses the reasons for the use of antitussives in young children, which include allaying parents' concerns about their child's cough and because of the relative safety and placebo effect of these OTC agents when dosed appropriately. The authors also describe reasons against the use of these agents in this population, citing the benign nature of acute cough, the lack of evidence supporting the use of these products, recommendations and warnings by both government agencies and professional societies against the use of these products, and their abuse potential.
The authors reinforce the safety precaution that codeine-containing antitussives should not be used in young children. Honey has been found to be beneficial for cough, but it should only be used in children older than age 1 year because of the danger of infant botulism. Older children and adults can neutralize the harmful effects of botulinum spores in the gut.
The review also recommends the use of saline nasal sprays, nasal suctioning, and vapor rubs, as well as hydration and the use of antipyretics when appropriate. The authors stress that parents need to follow dosing and age recommendations on CCMs' labeling and that these products should only be used short-term.
As front-line workers, community pharmacists are often asked for advice on the use of CCMs in pediatric patients. This paper provides guidance on the use of antitussives in young children while highlighting the importance of discussing treatment options with patients' pediatricians in order to avoid any untoward effects from these products.
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