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.

Tests in Children Lacking

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.

The concerns were raised last Thursday by a group of 15 prominent pediatricians and public health officials, who petitioned the federal government to look into the matter further.

In a press briefing, Ganley revealed that most of these drugs -- and other classes of drugs altogether -- were never tested in children.

"Back in the 80s and 90s, there was a recommendation from the expert panel to extrapolate the dosing of these ingredients based on taking a fraction of the adult dose," Ganley said. "For example, for [children aged] 6 to 12, take one-half the adult dose. For [children aged] 2 to 6, you take one-quarter of the adult dose."

Ganley added that today, new drugs entering the market are required to be studied in children.

But no such requirements exist for previously approved drugs. And current research suggests that there could be real impacts to the lack of data available on the use of these older drugs in children.

In a study conducted last year by the FDA, researchers attempted to determine how often medications approved for adults work differently on young people by testing them on children.

Of the approximately 300 drugs that were tested on children in the past nine years, 118 subsequently had their labels changed to instruct doctors if, when and how they could be used in kids.

ABC News reviewed government documents on these 118 drugs and found that about half had problems.

About one out of four drugs approved for adults had serious safety problems when used in children, including risks of pneumonia, seizures, stunted growth and other detrimental health effects.

And a full 20 percent of the drugs simply did not work on children. That, too, can have tragic effects, especially if a doctor is under the mistaken impression that his or her patient is receiving important medicines that actually have a beneficial effect.

Over the past decade, the number of drugs tested and approved for children has increased somewhat due to federal regulations providing financial incentives to pharmaceutical companies.

But Ganley said opening the door to requiring tests on all existing medications to prove they are safe for children would be problematic, as the vast majority of these medicines would have to be tested in children.

Over-the-Counter Concerns

Over-the-counter products can also present a special risk for kids and babies, since many nonprescription drugs have also never been tested specifically in children.

"With all the products on the market, it can be very confusing exactly what you are giving your child," said Texas pediatrician Dr. Ari Brown, co-author of "Baby 411: Clear Answers and Smart Advice for Your Baby's First Year" and "Toddler 411: Clear Answers and Smart Advice for Your Toddler."

"Parents will also guesstimate what dose to give their child by using a product that is intended for a child over 6 years of age to an 18-month-old, for example."

Brown says "combination" products -- those that contain multiple medications in a single dose -- can further increase the chances that a child is receiving an inappropriate dose of a medicine.

"[Parents] may give two products that both contain the same ingredients," he said.

As with prescription drugs, hospitals treating young patients lie at the center of concerns over the use of nonprescription medicines in children. Many of these medications are given to children in these settings, and the doctors and nurses at hospitals are often charged with the duty of instructing parents on how to properly administer these drugs to their children.

"We have been trying to educate our residents and nurses about the use of all cough and cold medicines," said Dr. Neil Herendeen, associate professor of pediatrics at the University of Rochester Medical Center.

"We are worried both about the potential harm for young infants and toddlers, as well as the waste of money on ineffective medications."