Over the Counter but No Longer under the Radar — Pediatric Cough and Cold Medications

H1 Antihistamines: Current Status and Future Directions

“…Because of lack of efficacy data and concerns about safety, manufacturers in the United States and some other countries are being urged to voluntarily recall over-the-counter cold and cough preparations for children younger than 2 years and to add the warning, "Do not use to sedate children," to the label of first-generation H 1 -antihistamine preparations [5,50]. …”

What is the evidence for the safety and efficacy of over-the-counter cough and cold preparations for children younger than six years of age?

“…In short, there is little to no evidence to support the efficacy of OTC cough and cold preparations in children, but there are several concerns regarding the safety of these products (17). It appears that they have been a market mainstay due to their relative low cost and the perception of parents and clinicians that they improve symptoms and allow for easier tolerance of coughs and colds (2,3), as well as a general perception of safety.…”

“…However, in light of extensive reports of no objective efficacy coupled with significant adverse events (especially in this age group), a risk-benefit analysis clearly suggests that the use of these products in children younger than six years of age should not be encouraged or supported. Furthermore, parent education about the self-limiting nature of coughs and colds and the lack of efficacy of these drugs is needed (4,17). Supportive therapies, such as humidified air, bulb suctioning, saline nose drops and increased fluid intake continue to receive support in the literature (4,12) and should be used as needed.…”

Cough and Cold Medication Adverse Events After Market Withdrawal and Labeling Revision

“…[1][2][3][4] Studies had not demonstrated CCMs to be more effective than placebo in young children but had linked CCMs to significant numbers of emergency department (ED) visits and, in rare cases, infant deaths. [5][6][7][8] The Food and Drug Administration (FDA) formally supported this withdrawal in January 2008. 9 The next year, ED visits and calls to poison centers due to CCM adverse drug events (ADEs) involving young children declined.…”