DR.
WALLS is a community-based pediatrician and a past member of the
American Academy of Pediatrics Committee on Drugs and a member of the
steering committee of the Provisional Section on Complementary,
Holistic, and Integrative Medicine.

The
use of over-the-counter cough and cold preparations in infants and
young children has evolved into an extremely common practice and over
the last decade there has been an increasing awareness of the
potentially toxic—and unfortunately potentially fatal—consequence. We
are becoming increasingly aware that infants and children are not
merely small adults and that studies that centered on the adult
population cannot simply be extrapolated to the pediatric.

Assumptions
made previously—although well intentioned—have been shown to be
erroneous and potentially dangerous. These dangers became compounded by
the plethora of combination OTC cough and cold products that appeared
on market shelves proclaiming symptomatic relief and touting “doctor
recommended” claims.

The recent voluntary
and perhaps soon to be mandatory withdrawal of infant cough and cold
drug preparations is a reflection of the growing concerns regarding
safety and efficacy of all medications. All involved in the voluntary
withdrawal should be applauded for the efforts. However, the
recommendation of the recent Nonprescription Drug Advisory Committee of
the Food and Drug Administration is to restrict the use of such
combination products in children less than 6 years of age as no data
could be provided demonstrating efficacy in this population.

Our
educational efforts to teach medical care providers and our patients
the benefits, risks, and limitations of medications is identical to our
efforts to change antibiotic prescribing practices and consumer
expectations and demands. Physician-directed medical care has largely
eroded away, evolving into a market place, media-driven,
Internet-influenced consumer-demand phenomena. The idea that there is a
medication for every condition, for every age, is pervasive. Parents
are compelled and driven to obtain symptomatic relief for all medical
conditions, and with the market explosion of direct-to-consumer
advertising of medical products and preparations—as well as the
remarkable number of products available—it was only a matter of time
before we began to see increases in medication errors and untoward side
effects. Where do we go from here?

Until
studies show the effectiveness and safety of a medication in infants
and children, that medication should not reappear in the marketplace.
The same standard should be held for all patients, of all ages. We, as
providers of care, must be aware of the potential misuse of medications
not intended for infants and children when and if the combination
products are no longer marketed for this age group, but are still
available OTC.

We must educate our patients
that there are steps that can be taken that may provide symptomatic
relief and can be provided in a safe manner. Saline nose sprays and
drops can provide significant relief from irritation of the nasal
passages. The nasal suction bulbs, when used properly, can provide
relief as well. The simple maneuver of elevating the head of the bed
and/or crib can significantly reduce the pressure on the sinuses and
nasal passages as well as the entire respiratory tract. Cool mist
vaporizers can decrease the irritation of the upper airway. Aromatic
therapies may become increasingly popular, and we must be aware of
their potential benefits as well as dangers. The use of camphor and
eucalyptol will likely increase as they are effective agents. However,
when such products are in the home there is always a risk of ingestion.
Camphor continues to be a common product accidentally ingested in the
home.

The use of herbals has become
increasingly popular, yet there are few safety and efficacy studies
demonstrating potential benefit in infants and children. There is a
tendency to consider herbals as GRAS (Generally Regarded as Safe) and
with the majority of dosing regimens, exactly the same assumptions are
made that were made with the OTC cough and cold preparations.
Fortunately, there is increased interest in performing studies that
demonstrate the safety and efficacy of the use of herbals in infants
and children. I encourage all health care providers to become
increasingly knowledgeable in the use of herbals as our patients are
demonstrating that they are using them. The more we educate our
patients about their medical care and the dynamics of illnesses and of
wellness, the better we will surely improve the quality of their care.