Safety and efficacy of over-the-counter cough and cold medicines for use in children.
BACKGROUND
Over-the-counter (OTC) cough and cold medications have been used widely for years and continue to be a preferred choice for temporary relief of symptoms of upper respiratory tract infections in children. These medications are being placed under extraordinary scrutiny in the pediatric population due to the lack of conclusive evidence about their therapeutic efficacy and increased reports of associations with serious adverse events and even mortality.


METHODS
A PubMed search was conducted to identify articles published up to August 2009 describing the efficacy and safety of OTC cough and cold medications in children. The objective was to provide an overview of the relevant literature and regulatory history and to comment on the available data on this important topic.


RESULTS
The paper provides a detailed up-to-date review of the key efficacy and safety studies published on the subject. In addition, the reader is presented with an overview of the regulatory history and recent developments surrounding the use of OTC cough and cold medications in children in the US.


CONCLUSIONS
This review confirms the lack of efficacy of OTC cough and cold products in children and reaffirms that although the overall incidence of related serious adverse events is low, such events continue to occur. The conclusions in this paper support a recommendation that OTC cough and cold medications should not be given to infants and very young children. Furthermore, additional research is needed to evaluate the safety and efficacy of these medicines in the broader pediatric population.
Vassilev
Zdravko P
ZP
Epidemiology, Covance Periapproval Services, 555 North Lane, Suite 6000, Conshohocken, PA, USA. zdravko.vassilev@covance.com
Kabadi
Shaum
S
Villa
Raul
R
D000367:Age Factors; D000996:Antitussive Agents / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D002648:Child; D003139:Common Cold / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D003371:Cough / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D006801:Humans; D004366:Nonprescription Drugs / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome
D000996:Antitussive Agents; D004366:Nonprescription Drugs