Giving Newborns Medicine Is a Dangerous Guessing Game. Can We Make It Safer?

January 5, 2017

(STAT News) – Pharma companies are afraid to test drugs on babies because they’re so vulnerable, and because the risk of liability is so high. Parents and doctors say they’re wary of enlisting newborns as “guinea pigs” in clinical trials. The result: An estimated 90 percent of medications administered to newborns are not approved by the Food and Drug Administration for use in children so young. That means neonates — premature and full-term infants less than 28 days old — are routinely treated with drugs that are not adequately tested for safety, dosing, or effectiveness.