Pediatric Drug Testing Update

In: Drug

13 Jun 2010


Children obviously need medicines, medical health professionals agree, but they are considered “therapeutic orphans” when it comes to drug development. Most drugs are studied, approved, and labeled for use in adults. To use one of these approved drugs for the same disease in children, it is important to know which doses work best in children and which kinds of adverse reactions are likely to occur. Other drugs are used for diseases specific to children, and adequate and well-controlled studies of their effectiveness and safety are needed. The physician labeling on the product normally includes a disclaimer that safety and effectiveness have not been established for use in children. That is the usual procedure with most of today’s drugs. Even morphine, which is a standard, necessary pain medication, has not included explicit labeling for use in children.

Pharmaceutical firms have had little incentive to study drugs for use in children because the population—and therefore the financial return—is likely to be small. Moreover, drug testing in children is more complicated than testing in adults. Pediatric drug trials are often performed in children’s hospitals and can be more involved because great effort is made to ensure that parents and children understand the consequences of taking medications. Children are less likely than adults to be used as control subjects in clinical trials; most children in trials have the disease being studied. There is greater reluctance on the part of the medical community to use drugs in children for whom there would be no potential benefit.
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It is naive to believe that the solution to this problem is to simply give children lower doses of the required drugs. Young children sometimes metabolize or absorb drugs at different rates than adults do, and therefore it is difficult to estimate a suitable dose from a child’s size. The same holds true for older adults, when compared with younger adults. In recent years, the U.S. Food and Drug Administration (FDA) has paid more attention to establishing specific dosages for elderly patients, and the same kind of attention is needed for children.

At present, fewer than 25% of all FDA-approved drugs include an indication for use in children. Nevertheless, nearly all drugs currently on the market in the U.S. have been used in patients younger than 18 years of age. It is legal for physicians to prescribe a pediatric drug that is currently on the market but that has no labeling for children. Physicians may legally prescribe approved drugs for whatever uses they deem appropriate, according to their medical judgment. 

The question is, how do pediatricians know the proper dose of a drug if it is not specifically labeled for children? The answer is, there is no standard source of information. Textbooks on pediatrics usually mention drug dosages, but the source of the information is seldom specified and the reliability is questionable. In addition, therapeutic regimens for children are often based on individual case reports, case series, and small or limited studies published in medical journals or based on past experiences of pediatric clinicians.

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