FDA to re-evaluate children's cold remedies
After many months of refusing to act, the FDA announced on August 25 that it will begin a reassessment of children's cold remedies. A group of pediatricians had been seeking this action since March of 2007, reacting to widespread concern that children's cold remedies are ineffective and perhaps dangerous.
The Atlanta Journal Constitution reported that the agency intends to investigate children's cold remedies and formulate new standards for their sale. In response to an earlier investigation, the manufacturers involved have already acknowledged that the products should not be administered to children under age two, and pulled these products from retail shelves prior to a scheduled meeting of experts. That expert panel, which ultimately convened in October of 2007, concluded that the medications had not been proven effective for children under age 12, should not be used with children under age 6, and should be the subject of appropriate research.
The first step in the new investigation will be a special hearing scheduled for October 2 of 2008. These medications were initially approved for administration to children without research on children, and clinical results and dosages were based upon extrapolation from adult research studies. The medical and pharmaceutical industries now recognize that children are not merely "small adults": their metabolism and chemistry are different, and infant medications should be tested on infants for safety and efficacy.