- Nonprescription (over-the-counter, OTC) cough and cold medications are frequently used in the treatment of upper respiratory tract infections and in the treatment of allergic diseases despite recent data that these medications have not been proved to be effective in treating cough and cold symptoms in young children. A survey conducted from 1999 to 2006 among participants aged 0 to 17 years old revealed that in a given week 10.1% of US children use OTC cough and cold products. The class most often used was decongestants such as pseudoephedrine (6.1%) followed by first-generation antihistamines such as diphenhydramine (6.3%). Combination products accounted for 64.2% of all cough and cold medications used. Concerns for toxicities associated with the use of these products have been a popular topic of discussion in recent years. There are a wide variety of rare but serious side effects associated with the use of these products, including convulsions, death, rapid heart rate, and acute mental status changes. In 2004, The Toxic Exposure Surveillance System documented nearly 90 000 calls and 3 accidental deaths associated with the use of OTC cough and cold products among US children. The Centers for Disease Control and Prevention linked these medications to more than 1500 emergency department visits in 2004-2005. In another study, a panel of experts reviewed all reported pediatric fatalities from The National Poison Database System of the American Association of Poison Control Centers, Adverse Event Reports submitted to the major manufacturers of nonprescription cough and cold products, the Food and Drug Administration (FDA) briefing materials for its advisory committee meeting on October 18-19, 2007, a Citizen Petition to the FDA submitted on March 1, 2007, and the general medical literature, and they found a total of 189 US deaths in children younger than 12 years. It was concluded that 118 of those cases were possibly related to the use of nonprescription cough and cold medications. These concerns prompted an FDA review of the safety and efficacy of OTC cough and cold medications for children. In January 2008, the US FDA issued a Public Health Advisory for patients and caregivers, recommending against the use of OTC cough and cold medications in children and infants younger than 2 years. Charles Ganley, MD, director of the FDA’s Office of Nonprescription Products, stated that “these medicines, which treat symptoms and not the underlying conditions, have not been shown to be safe or effective in children under two.” To analyze our local patterns of medication use and compliance with the FDA recommendations, a quality assurance project was performed.
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