Should Adult Drugs Be Childproofed?

March 8, 2007 — -- Many of the medicines children receive while hospitalized have only been tested in adults.

And often these drugs may have different -- and detrimental -- effects on younger patients.

A new report emerging from the largest ever pediatric study in the United States found that nearly 80 percent of hospitalized children receive medications that have never been tested and approved for children.

The study appears in the March issue of the Archives of Pediatrics and Adolescent Medicine.

"Since a lot of these drugs have not been studied in children, dosage and side effects are a very real problem," said study leader Dr. Samir S. Shah, a pediatrician specializing in infectious diseases at the Children's Hospital of Philadelphia.

"While we think they may be safe, there is a lack of information for these patients."

This lack of research data means doctors are usually left to assume that if a drug works in adults it will work safely in children.

Plus, using these drugs in children is not illegal; the Food and Drug Administration leaves it up to doctors to determine whether a given treatment or medication is appropriate for a particular patient. And in some cases, the drug at hand is the only option for a gravely ill child.

"Sometimes not treating these patients is not an option," Shah said, noting that drugs approved only in adults may be the only choice when a child has a life-threatening condition.

But medical professionals worry that child patients cannot simply be treated as if they were small adults, since a child's body sometimes processes drugs at a faster or slower rate.

In some cases, this means that many of these drugs can be ineffective. Worse, they may even be harmful to children's health.

Last week, Dr. Charles Ganley, director of the Food and Drug Administration's Office of Nonprescription Products, responded to concerns that certain cough and cold mixtures marketed to children were in many cases ineffective, and even harmful.