How Safe Are Children’s Cold Medicines?
Federal drug regulators are carefully studying common children’s cold and cough medicines because they beleive that they have not been studied enough before being given to children. One of the top Food and Drug Administration officials, Dr. Charles J. Ganley, stated that the agency is “revisiting the risks and benefits of the use of these drugs in children,”. They are concentrating more on what effect it has on children who are 2 and under.
Ganley stated that many cold and cough medicines that are being given over the counter have not been tested enough in children. “We have no data on these agents of what’s a safe and effective dose in children.” At this time the FDA cannot say if new regulations will come from this new safety review or not. Many pediatricians and public health officials have requested that the agency bar drug manufacturers from marketing such remedies as Toddler’s Dimetapp, Infant Triaminic and Little Colds to children under 6.
A recent study by the federal Centers for Disease Control and Prevention revealed results that proved that more than 1,500 children under 2 had experienced serious health problems, and three died, after taking common cold medicines in 2004 and 2005. The American College of Chest Physicians last year recommended avoiding using cough and cold medicines in children, especially young ones.
In above-normal doses, cold medicines can lead to heart arrhythmias, and some have been connected to hypertension and strokes when they have been taken in high doses. In rare cases, children have had medical problems after taking recommended doses also. The president of the Consumer Healthcare Products Association, which represents companies that sell over-the-counter cold drugs, stated that the medicines had FDA approval and had been used for decades. They should be taken only in recommended doses, association president Linda A. Suydam said.
The pediatricians who petitioned the FDA have acknowledged that children’s cold medicines were generally safe in recommended doses, but they said overdoses were common because many children were given more than one medicine. They also questioned the drugs’ effectiveness in children. Many cold and cough drugs won FDA approval decades ago, when the agency’s standards were less strict.