Despite their widespread use by parents and caregivers, over-the-counter (OTC) cold and cough medicines have carried a warning by the FDA since 2008, and still have the potential to cause serious adverse events in infants and children. Conservative therapies, including nasal suctioning, humidification, and nasal saline, should be recommended over routine use of OTC cough/cold products in infants and children, according to a new commentary published in the May 2010 issue of Otolaryngology - Head and Neck Surgery.
According to the commentary, OTC cough/cold medications are commonly used in young children, to provide relief of symptoms of upper respiratory tract infections, including acute otitis media, the common cold, and rhinosinusitis. The Sloan Survey, a random telephone survey of medication use, reported on prescription and OTC medication use by 2,857 children under 12 years old, between 1998 and 2007 in the 48 contiguous United States. Among the commonly used medications were acetaminophen-pseudoephedrine, cold/fever medication (unspecified), dextromethorphan-pseudoephedrine, and cough medication (unspecified). The number of children given OTC medications was more than twice that of children given prescription medications in a given week.
"Parents may administer these products to children with good intentions, as they are medications that are widely used to treat adults with upper respiratory conditions," said commentary author David E. Tunkel, MD. "Data supporting their efficacy, however, do not exist. Evidence does exist of the potential for significant harm from use of these products in young children."
Pediatric otolaryngologists will often see children, physician-referred or self referred, for treatment of refractory upper respiratory tract infections. Some of these children will have been treated with cold/cough medications, and some of the parents will request such medications. The authors state that this presents otolaryngologists with a unique opportunity to educate patients and parents about this issue and to recommend treatment alternatives for home use.
The authors further state that recent regulatory changes have altered the labeled age indications for OTC cough/cold products, and this may change again in the future. Conservative measures such as humidification, analgesia, and irrigation should be considered as adjunctive treatment of upper respiratory infections, including the otitis media and sinusitis (acute or chronic), that physicians see in children. The authors urge continued study of the OTC medications to further examine the risk-benefit ratio they pose for infants and children.