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. As a result, the number of medications being tested in children has jumped from 114 in 1990 to 217 last year, according to the Pharmaceutical Research and Manufacturers of America.
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. Even before the dangers of Propulsid were clear, doctors were enthusiastically prescribing the drug for babies despite the fact that the label carried no information on safety and effectiveness in children. 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.