Winter/Spring 2008

The end of 2007 saw a frenzy of activity in the press over the use of over-the-counter medicine in children. In this age of evidence-based medicine, the effectiveness and safety of these medications has been questioned. Many parents are now left wondering what they can do to keep their kids comfortable during a cold.

For many years drug companies have been marketing products for relief of common respiratory symptoms in children. Antitussive products for cough “suppression”, expectorants to “loosen” phlegm, decongestants to clear a stuffy nose and antihistamines to dry up drainage have been sold in various combinations for decades. However, the studies that support the use of these products have only been done in adults. Dosing for children was not established by any study but by basing a child’s dose as a fraction of the adult dose. The medical community has been increasingly critical of the notion that what works for adults must also work for children. Clinical studies of these medicines have shown no advantage compared to placebo (no medicine) in children.

It may be alarming for parents to learn that these medications are also associated with a number of accidental deaths in young children. Since 1969 there have been 123 reported fatalities in children under six associated with either antihistamine or decongestant use. Most of these cases were related to accidental ingestion, improper measuring devices or inadvertent overdose with use of multiple products.

In light of these facts, the Food and Drug Administration (FDA) issued a public health advisory last August that recommended the following:

• Do not use cough and cold products in children under two years of age unless told to do so by a healthcare provider.
• Do not give children medicine that is packaged and made for adults.
• If other medications are being given, the child’s healthcare provider should review and approve their combined use.
• Read all of the information on the “drug facts” box on the package label so you know the active ingredients and warnings.
• For liquid products use only the measuring device packaged with the medicine.

In response to the FDA’s advisory, the Consumer Healthcare Products Association announced the voluntary withdrawal of all 14 cough and cold products labeled for use in infants and children less than two years of age. This pharmaceutical industry trade association evidently disagreed with the FDA’s assertion that studies should be conducted in children beyond two years of age to determine if the medicines actually work as they claim. However they have agreed to conduct studies to attempt to clarify an age-appropriate dose for children.

Within the next few years more will be known about appropriate doses for children between 2 and 12 years of age. It’s possible that these recent developments may inspire clinical research to determine if these medicines have anything better to offer than nothing at all. But the pharmaceutical industry may not venture into such research that might continue to fail to prove any benefit of their products in children. The following FDA web site may be useful for those interested in following the future developments: http://www.fda.gov/cder/Offices/OTC/consumer.htm

In the meantime, it seems that we have to rely on what has long been accepted as beneficial to comfort the common cold: fluids, gravity and time. Intranasal saline and bulb suction in addition to a cool mist humidifier are recommended for relief of congestion. Plenty of fluids and elevation of the head and chest (when appropriate for age) can be useful for relief of cough. If these simple measures do not bring relief to your child please contact your Partners in Pediatrics’ provider for further discussion.