Todd Reynolds MD
OTC Cold Meds
By
Mar 19, 2008 - 1:58:34 PM

The use and marketing of over-the-counter cold medicines for children has been allowed by the FDA since 1976.  At that time, the FDA determined that these medicines could be marketed for use in pediatric populations as “generally considered safe and effective.”
However, since then the overall safety of these medicines in certain age groups has come into question.

The Food and Drug Administration (FDA) has recently issued a warning against using any over-the-counter cold preparations in children less than two years old.  It is expected that the warning may be extended to include children under the age of 6 years old.

The warning was officially released this year, but was predicted since the latter part of 2007.  At that time, study of the medications’ use in children, particularly infants and toddlers, had shown an increased risk of adverse outcomes.  

Study regarding the use of these medicines in children revealed some important information that led to the FDA ruling.  Over the past few years, approximately 7,000 children age less than 6 years old visited the emergency room yearly as a result of taking these medications.  Two-thirds of this number was due to unsupervised ingestion of the medicines.  About one-fourth of cases were with proper use of the medicines.

The reasons for the ER visits varied, but most were due to allergic reactions to the cold medicine.  This could include serious anaphylactic reactions that could be fatal.  The next most common reaction was excessive neurologic symptoms such as drowsiness or unsteadiness in the child.  

Most OTC cold medicines contain a mixture of drugs aimed at easing the symptoms of the common cold.  Ingredients may include decongestants such as pseudoephedrine or phenylephrine; dextromethorphan for cough; antihistamines such as diphenhydramine (Benadryl) or chlorpheniramine for runny nose; and a pain and fever reducer such as acetaminophen.  If an adverse reaction does occur while using these medicines, it is often difficult to determine, which ingredient is the culprit, since the combination can contain three or more ingredients.  

Another problem with these medicines is that some parents may find it difficult to measure out the correct dosage for a small child.  Charts on the box may be based on the age or the weight of the child.  Often there is no dosing recommendation under the age of two years old.  Also, the measuring devices provided with the medicine may be hard to read or ambiguous.  This can lead to overdosage.       

While these medicines are considered safe when used properly, many of the companies who had been marketing cold medicines for this age group had already stopped marketing these products last fall.   

Finally, studies on the effectiveness of over-the-counter cold medicines have repeatedly shown the same result; that is, they generally provide no more relief of cold symptoms in children than using no treatment at all.  

Parents are better off using simple conservative remedies in treating their child’s cold.  These include plenty of rest, fluids and healthy foods; and humidifiers, nasal saline sprays, and suction for nasal congestion and drainage.  Since a typical cold is self-limited, lasting anywhere from seven to ten days, time and support may be all that is needed.      

The content in this column is for informational purposes only.  Consult your physician for appropriate individual treatment.  Dr. Reynolds practices Family Medicine in Chesterfield.

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