January 26, 2001
and Over-the-Counter Medications: The Rationale Behind Dosing Guidelines
By Christopher Turf, R.Ph.
spiraling cost of health care is a disturbing economic trend. One
effect of this upward spiral is that many Americans are educating
themselves about their health, and as a result, are attempting to
self-diagnose and self-medicate.
Certainly, the over-the-counter (OTC) medications available at
every grocery store, pharmacy, and convenience store can be effective
and cost-saving tools to maintain good health. In fact, the president
of the Nonprescription Drug Manufacturers Association asserts that
the use of OTC products to self-medicate has become an essential
part of American health care, and yet such use is extremely low-cost.
Six out of ten medications bought by consumers are nonprescription,
but total spending for these medications is less than two cents
of the U.S. health care dollar.
However, parents should be aware of the many safety concerns regarding
the use of these products for young children.
A recent study showed that only 34 percent of the Americans
surveyed actually drink the recommended amount of water
-- eight 8-ounce servings per day.
Parents of children under 12 are often confronted with labeling
that gives guidelines for adults only. And the danger in parents
medicating children with these products is that young children are
physiologically different from adults. Therefore, medicines than
can be easily metabolized by a full-grown person may not be well-tolerated
by a young child. Before deciding, for example, to halve the suggested
adult dosage on an OTC medication, parents should first understand
why the FDA restricts the use of certain products for kids.
There are a lot of OTC products specifically designed for youngsters,
like Children's Tylenol, but other medications -- such as flu-symptom
relievers or antihistamines -- are made for adults but are not widely
available for kids. And there are things to be concerned about when
trying to adapt these medications for children.
Reasons for FDA age restrictions
Unacceptable risk: Patients below a certain age might experience
adverse effects too severe to warrant the use of a product. In cases
like this, the risks could outweigh the benefits an OTC product
could provide. Antihistamines, for instance, do not have labeling
for children under the age of 6 because of the serious side effects
small children might encounter. One antihistamine has even been
associated with sudden infant death syndrome (SIDS).
Inability to use the product properly: In some cases young
children may not be capable of properly using a product. Misuse
of certain products can place a child's health at risk. An example
is home fluoride treatment, which is not recommended for use in
children under 6.
Little need for the product: Age limits are often placed
on products when the FDA cannot envision a situation in which a
child younger than the specified age would need the product. Sunscreens,
for example, have a minimum age of 6 months placed on them; the
FDA reasons that children below 6 months should not be exposed to
the sun for a length of time that would warrant sunscreen use. Pediatrician
Mark Schane, M.D., agrees, although he says he doubts that sunscreen
use would harm an infant.
Condition reflects serious underlying problem: This term
reflects a concern that a product might treat a condition that,
in children, could be serious enough that a doctor should be consulted.
Hemorrhoidal treatments, for instance, are labeled for use only
by persons over the age of 12. Hemorrhoids in children may indicate
serious conditions like cystic fibrosis, parasitic infection, structural
abnormalities, or conditions related to liver disease.
Physiological differences: Dr. Schane explains that the
physiology of young children is different from that of adults; children
are still developing physically. Drug metabolism and elimination
may be faster or slower in young children than in adults.
This is why well-meaning parents shouldn't simply guess at creating
a lower dosage for their child.
Time on the market: Age limits on an OTC product often reflect
the length of time the medication has been available without a prescription,
as well as the amount of experience the public has had with the
product. Teething remedies have enjoyed a relatively long duration
on the market, and have been used by large groups of children. Such
products are approved for use in patients as young as 4 months of
age. In contrast, an anti-inflammatory that recently became available
over the counter hasn't been used much in pediatric populations
and therefore is not recommended for people under the age of 16.
The other side: Is the FDA holding out on us, or are the manufacturers?
While there may be a strong demand for OTC products specifically
tested and labeled for kids, it's probably not the manufacturers
who determine which products go on the market. Manufacturers have
done numerous studies that have established dosing for young children;
the FDA, however, distributes this information only to medical professionals.
In other words, if you want to know whether it's safe to give your
favorite new analgesic to your child, only a consultation with your
doctor can tell you the answer.
Doctors can provide dosage information that's not found on the
labels of OTC products -- guidance that stems not only from the
information found only in professional labeling, but also from a
physician's own experience with the medication. This may mean having
to go to the doctor every time a child gets sick even if you, the
parent, know it's the same bad cold or flu you yourself just had.
Only a doctor can provide the proper dosing measurement and tell
you if an OTC flu-symptom medicine is appropriate for a child.
So, should the FDA relax their standards and revise age limitations
for the convenience of consumers? Or should the FDA even allow consumers
to view the information available to doctors in professional labeling?
In fact, the FDA has allowed companies to provide dosing information
for younger children on their products -- provided that the product
has proven safe in additional manufacturer studies in such children.
In fact, the FDA currently offers incentives to drug manufacturers
to perform additional studies with children. These incentives include
patent extension and market exclusivity -- the latter of which limits
competition from other companies for a given period of time.
And yet, the manufacturers haven't responded strongly to these
opportunities. Often they are unwilling to do expensive clinical
studies with children as they can be time-consuming, increase the
company's liability, and in the end, may not increase profits.
The FDA seldom deviates from established policies. If recent FDA
rulings regarding OTC medications are any barometer, it is unlikely
that the agency will make any radical changes. Most likely, it will
continue to err on the side of caution. And as a result, it is in
the consumer's best interest to follow product labeling -- or to
consult a doctor.