By John McKenzie

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So finds researchers who have sifted through reports filed with the Food and Drug Administration and found that each year at least 2,000 children, 2 years old and younger, suffer adverse reactions to medications.

"The type of adverse reactions: cardiac arrest or severe cardiac rhythm disturbances that could result in death; kidney failure and severe damage to the kidney, liver toxicity..." said lead researcher Thomas Moore from the Center of Health Services Research and Policy at the George Washington University School of Public Health and Health Services in Washington, D.C.

This analysis is published in this month's issue of the journal Pediatrics.

Part of the problem is that most drugs given to children have only been tested in adults, for whom most of these medications were originally developed. So giving a child the the right dose often boils down to "guesswork."

"The potential risk is that the drug dosages may be too high for that child's liver and kidney to excrete the toxic substances," said Dr. Carol Blaisdell of the University of Maryland.

The Pediatric Rule

After years of asking drug companies to test more medications in children, the FDA finally ordered them.

It implemented what's called the "Pediatric Rule," which says that drugs commonly used in children had to be studied in children, and that has been the practice for three years.

"There have been more studies done on pediatric patients in the last three years than in the 30 years before that," said Dr. Richard Gorman, interim chairman of the Committee on Drugs for the American Academy of Pediatrics in Washington, D.C.

But that momentum is suddenly in jeopardy. Last month a federal court ruled that the FDA does not have the authority to require drug companies to do pediatric studies.

"It's definitely going to set us back," said Blaisdell. "It's going to make it much more difficult for pediatricians to make appropriate decisions about dosing for pediatric drugs." Pediatricians are calling on Congress to get involved, to make the Pediatric Rule the Pediatric Law.