Pediatric cold medicines
The FDA continues to wrestle with the question of the safety and viability of pediatric cold medicines. These medicines were marketed for years before the FDA became involved in approving over-the-counter medications, and as a result they were "grandfathered" approval without normal testing requirements. In addition, at the time the FDA did not impose any testing requirements or a sundown date on the approval, so they have never been tested for safety or efficacy. The handful of clinical trials that have been undertaken suggested that they are no more effective than a placebo.
As one pediatrician on the panel explained, children are not, metabolically, just little adults. They respond to medication differently than do adults. No medications should be approved for kids without appropriate testing on kids. There are more than one hundred documented cases of deaths of children related to these medications, and the Advisory Panel has recommended taking them off the market. Some experts would recommend that they be removed from the market for all kids up to age 12. The panel noted that there were more than 1500 reported cases of serious childhood health problems associated with common cold medicines administered to children under two years of age, during 2004 and 2005 alone.
As this is a 2 billion dollar market, manufacturers have vigorously opposed removing these medicines from the market. They have agreed to removal of some medicines being marketed to the parents of very young children and they have suggested that clearer product warnings would be an adequate safety measure. Further information on these issues can be downloaded from websites for NPR and the New York Times Archives.