Studies Look for Safe Dosages for Children

There is more to prescribing medicine to children than meets the eye.

Studies under way at Baylor College of Medicine and Texas Children's Hospital have been designed to determine the proper doses of medication for children and eliminate some of the current guesswork.

"One practice has been to give a child who weighs half as much as an adult half as much medication," says Dr. Susan Blaney, associate professor of pediatrics at Baylor. "That isn't necessarily a rational way of prescribing. A lot depends on how the body handles the drug."

Eight medications, from antibiotics to antacids, are the focus of studies. The Houston site is one of 13 that serve as the Pediatric Pharmacology Research Unit Network.

The nationwide network gives investigators access to a large pediatric patient base and experienced physicians in a wide variety of subspecialties.

A primary purpose of the network is to provide the data necessary for FDA approval for new drugs and drugs already on the market that will be given to children.

"In the past, there has not always been adequate information on drugs used in children. Not only is there a difference in prescribing medication for children compared to adults, but there may also be differences in newborns, toddlers, and teenagers," Dr. Blaney says.

The way children's bodies metabolize the drugs at different ages will be a key factor in the studies. Age and organ function are the usual indicators in how a child will handle a drug, Dr. Blaney says.

"Weight is not necessarily a factor. You can have a 7-year-old who weighs 40 pounds and a 7-year-old who weighs 65 pounds, but their organ maturation and function could be similar," she says.

Two primary types of studies will be conducted. In pharmacokinetic studies, blood samples are drawn at regular intervals over a period of hours to determine how the body is processing the drug. In efficacy studies, the research focuses on how well a drug works in children compared to what is considered standard for that disease. The efficacy studies take a longer time.

In addition, the network is performing studies to evaluate the effect of genetics on drug metabolism.

"Physicians prescribing medicine want answers to these questions," Dr. Blaney says

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©2006 Texas Medical Center

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