THE Food and Drug Administration was right to order stern warning labels on over-the-counter toddlers’ cold medicines – but the reporting on the move could mislead many parents.
These medications have not been shown not to work in infants, or to pose inherent risks. The problem is that some parents fail to dose their children properly.
In 2004-5, some 1,500 infants under age 2 were taken to US emergency rooms for side effects to these treatments; three died. But virtually all were cases of improper use or overdose of the remedies.
Of course, 1,500 cases is miniscule compared that to the 3.8 billion-plusdoses of these medicines safely given to children every year. But the FDA can’t risk even a rare life because of a careless parent. And, since the common cold is not curable, cold medicines (which can only treat symptoms) are much less of a priority.
Infants often cry and spit, so administering an accurate dose can be difficult at best. And some parents use spoons to deliver the medicine – a far more inexact method than a medicine dropper. Parents have even tried to approximate the right dose using medicines intended for older children – a practice that can easily lead to overdose.
The medicines in question contain cough suppressants, anti-histamines and decongestants – all generally safe. But it certainly makes sense for a parent to speak with a pediatrician before administering these remedies, because they’re not cures. But it also makes sense for the FDA to insist on direct label warnings – especially for parents who can’t or won’t consult doctors.
A baby with cold symptoms may be suffering from fever, runny nose and cough. The most important things to do include hydration, bringing down the fever, suctioning or putting drops in the nose – and calling the doctor if the symptoms worsen.
Again, OTC cold medicines are intrinsically safe, but the FDA warning is correct. The danger here is not the treatments, but the approach of the parents who are giving them.
Dr. Marc K. Siegel is an associate professor of medicine at the NYU School of Medicine.