A decade after the U.S. government began trying to ensure that prescription drugs used to treat children are safe, doctors still have very little information to guide them.
For many years, the testing of drugs on children was regarded as unnecessary and unethical, but this resulted in medications being given to children with no testing at all. In 1997, the FDA Modernization Act gave companies six extra months to sell a drug without competition if they studied it in children, and the 2003 Pediatric Research Equity Act authorized the FDA to require companies to test new drugs on children before they are approved for sale.
But even today, about two-thirds of the thousands of medications given to children remain untested on them.
What little has been discovered thus far has been troubling. A highly effective adult migraine drug turned out to be worthless in children, and sometimes caused serious side effects such as strokes. An asthma inhaler could stunt children's growth, and a narcotic patch routinely used to relieve pain could cause fatal overdoses.
* Washington Post November 23, 2007