PEDIATRICIANS share a common reaction to the Food and Drug Administration's decision to require pharmaceutical companies to test the effects of new drugs on children: It's about time.
Only 20 percent of the prescription drugs on the market today have been voluntarily tested for safety and effectiveness on children. That means pediatricians too frequently are forced to guess when making critical decisions about the drugs and dosages they prescribe for their youngest patients.
And unfortunately, even a doctor's educated guesses can be deadly. The "gray babies" incident in the 1950s is the most notorious example. Eighteen infants died because their immature livers weren't able to process the antibiotic chloramphenicol. Researchers have also discovered -- after the fact -- that tetracycline stains children's teeth and that combining erythromycin and midazolam can cause unintended unconsciousness in youths.
Each of these problematic prescription drugs had been thoroughly tested on adults. But as Dr. George Dover, chairman of the Johns Hopkins department of pediatrics, points out, "Children are not little adults."
Frequently the best drugs for treating adult diseases like diabetes and depression don't work well for children with the same symptoms. And while some grown-up AIDS therapies hold promise for HIV-positive children, doctors have to "wing it" when deciding potentially toxic dosages.
That will change under the FDA regulations, which take effect April 1. Drug companies will be required to test new drugs on children. And they will have to provide detailed prescribing advice to doctors and parents.
The change is a natural outgrowth of an important medical realization: The safety and effectiveness of potent drugs can vary according to a patient's race, gender -- and age. And the best way to ensure patient safety is by more thoroughly testing the therapies in advance.
Pub Date: 12/03/98