Medications are blamed for birth defects, serious injuries or deaths in hundreds of children under age 2 each year, underscoring the need for more clinical testing of drugs in infants, researchers say.
Over a three-year period from 1997 to 2000, about 3,750 serious injuries, birth defects and deaths in children under 2 were linked to medications and reported to the Food and Drug Administration, according to a study in the November issue of Pediatrics.
The study, conducted by researchers at George Washington University and the University of Maryland, comes two weeks after a federal court said the FDA does not have the power to require drug makers to test adult medicines in children.
The study found 769 deaths and 664 cases of birth defects or disabilities possibly linked to drugs used in children or to medications taken by their mothers during pregnancy, delivery or breast-feeding.
“These results underscore the need for additional drug testing in the youngest pediatric patients and for carefully weighing the risks versus benefits of medication,” the researchers said.
Adult medications are commonly prescribed for children without clinical testing on youngsters because such studies can raise ethical and practical concerns.
“There is extremely limited testing of drugs, so it is very hard to know how to use them well” in children, said lead researcher Thomas J. Moore, a health policy analyst at George Washington University.
The researchers cautioned that when a report is filed about an apparent adverse drug effect, it does not necessarily mean the medicine was at fault.
Dr. Charles J. Cote, a pediatric anesthesiologist at Children’s Memorial Hospital in Chicago who was not involved in the study, said it is often hard to determine whether a very sick child died from the drug or the illness.