Born three months premature, the baby was enrolled in a clinical trial for an antifungal drug. He is now doing well. Born 15 weeks premature, he had been expected to endure a long hospitalization crammed with drug treatments, tests and possibly surgery. And when he developed a fungal infection, they knew additional medication would be required. A federal law passed in 1997 gave drug companies an incentive to test their products in children by offering a six-month patent extension on drugs so tested.
Doctors typically prescribe the drugs simply hoping they'll work as they do in adults.
The possibility of serious harm became apparent during research on the drug Propulsid, for gastroesophageal reflux, in 1999. Test drugs in children or allow untested medications to be given to them. But I think the evidence is coming down on the side of testing these medications in children. In the 1960s, numerous newborns died from the antibiotic chloramphenicol. And many other drugs have proved to be harmful in children in ways that were not discovered during testing in adults.