Pediatric Drug Development
First marketed in 1849, Mrs. Winslow's Soothing Syrup was available for teething and colicky babies. The company claimed that this product would greatly facilitate the process of teething, allay all pain and spasmodic action, regulate the bowels, and "give rest to mothers and relief and health to infants." However, Mrs. Winslow's Soothing Syrup contained morphine and alcohol, and caused coma, addiction and death in infants.
A second example is Elixir Sulfanilamide, an anti-infective drug which was considered a wonder drug when it arrived on the market in 1937. Attempting to produce a flavorful oral dosage form, the drug company used diethylene glycol, a solvent chemically related to antifreeze. By the time regulators became aware of the problem, there were more than 100 deaths, including many children. Congress responded to public outrage by passing the 1938 Food, Drug and Cosmetic Act.