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January 26, 2001
Children and Over-the-Counter Medications: The Rationale Behind Dosing Guidelines
Barbara Shone

By Christopher Turf, R.Ph.

he 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.

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