History is rife with examples of pediatric prescribing nightmares. In the late 1950s and early 1960s, for example, the antibiotic chloramphenicol was widely used to treat infections in infants. It was later determined, however, that children treated with the antibiotic had significantly higher death rates than untreated children. A series of studies found that infants metabolized the drug differently than older children and adults. As minors, they can't give informed consent.
Companies have concerns about legal liability.
And testing drugs in children is expensive and problematic. As a result, liquid formulas and those that can be administered intravenously and intramuscularly often must be developed. The aim is to study a drug in a child who has the potential to benefit from it in some way. In the future, under rules that go into effect in December, researchers will be required to submit pediatric data with their applications for FDA approval if that drug is expected to be administered to children. Technologies such as micro blood studies and computer-driven analyses have reduced the number of needlesticks and other unpleasant procedures children have to undergo.