Cough and Cold Medication Present Risk to Infants

Over-the-counter (OTC) cough and cold products are used for children because they are readily available. A recent paper examined clinical data and previous studies that have evaluated the efficacy of these medications in children. The authors showed that the effectiveness of these OTC medications in young children has not been demonstrated in clinical trials. In fact, there is a potential for overdosing errors by parents, which can be dangerous. It is recommended that conservative doses should be recommended for OTC drugs, especially in the case of infants.

Over-the-counter cough and cold medications contain various pharmacological agents like antihistamines, acetaminophen and pseudoephedrine. These products are commonly used in young children with symptoms of respiratory infections including the common cold and acute otitis media (middle ear infection). Previous research has shown that OTC medications are used almost twice as often as prescription medications in children. Pediatric medical care providers have been focusing on medical issues associated with the use of these medications. The authors analyzed data available from previous studies evaluating the usefulness of OTC cough and cold products and also focused on regulatory provisions in relation to these medications.

•    Recent use of OTC cough and cold products was reviewed, including FDA regulations regarding them.
•    The authors examined data from clinical trials and reviews of OTC cough/cold medications in children.
•    The recommendations of the American Academy of Pediatrics regarding use of cough products were also highlighted.
•    The risks associated with use of pediatric OTC cough/cold medicines were assessed.
Key findings
•    Six clinical studies that evaluated the use of cough/cold medications in children showed that these products offer no clinical advantage.
•    A study of oral antihistamine/decongestant products showed that it did not provide any benefit in reducing symptoms of upper respiratory tract infection in children aged 6 months to 6 years.
•    According to the American Academy of Pediatrics Committee on Drugs, there is no data to support the cough-suppressing effects of these agents in children. Also, the currently recommended dosages are not scientifically based. They have warned that significant adverse effects are possible with the use of these OTC products.
•    Data from the FDA over a 37-year period indicates that there have been 54 fatal cases potentially caused by decongestants and 69 fatal cases potentially caused by antihistamines.  Most of the fatalities were in children younger than 2 years of age.
•    As per FDA recommendations, OTC products for cold or cough should not be given to children younger than 2 years.
•    Simple remedies may prove to be more effective than the OTC products. Nasal saline irrigations are an effective treatment for symptoms of chronic rhinosinusitis, while honey may control cough better than dextromethorphan.

Shortcomings/Next steps
This is a general review of available literature on the use of OTC cough and cold products in children and does not provide a structured or statistical analysis of clinical data. For older children, no clear data or recommendations are provided, probably due to the fact that clinical data and relevant trials are scarce. The FDA may publish new recommendations for the use of OTC products for cough and cold in children aged between 2 and 11 in the near future. Large clinical trials of these products in different groups of the pediatric population are also required for clear recommendations to emerge.

Although over-the-counter cough and cold products are commonly used in children, parents need to exercise caution when administering the medication. The efficacy of these products has not been demonstrated as yet and there exists clear evidence of potential significant harm. Inadvertent overdosing is a real problem, as no standardized dosing schedules have been established. It is best to use conservative measures like humidification and nasal irrigation as optional treatment of upper respiratory tract infections. The use of the OTC cough or cold medications must be restricted to children for whom they have been specifically advised by a healthcare provider.

For More Information:
Over-the-Counter Cough and Cold Medications in Children: Are They Helpful?
Publication Journal: Otolaryngology, Head and Neck Surgery, May 2010
By Edward A. Bell; David E. Tunkel, MD; Blank Children’s Hospital and Clinics, Des Moines, Iowa; Johns Hopkins Medical Institutions, Baltimore, Maryland

*FYI Living Lab Reports Are Summaries of the Original Research.
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