During the two year period from 2004-2005, 1,519 infants and toddlers sought medical care due to adverse reactions to cough and cold medications containing pseudoephedrine. Further, the deaths of three infants younger than six months of age were linked to cough and cold medications during 2005.
It is not uncommon for children under two to experience adverse reactions to cough and cold medications. The U.S. Food and Drug Administration does not provide any dosing guidelines for dispensing cough and cold medication to children in that age group.
The cough and cold medications in question are available without prescription, although they may not be available on the shelves at your local pharmacy. Certain cold medication formulations are now only available behind the pharmacy counter. You may notice that if you read the directions for these medications that dispensing guidelines for children under two are absent. Further, there may or may not be directions to check with your healthcare provider before dispensing to children that young. Or, if that’s not the case, according to recent warning, it should or soon may be the case.
The adverse events associated with dispensing cough and cold medications to children under two years of age during 2004 and 2005 prompted an investigation by the Centers for Disease Control (CDC). This investigation prompted the CDC to issue a warning to parents against dispensing cough and cold medication to their children in this age group prior to consulting with a healthcare provider.
The CDC released this warning in its January 11, 2007 Morbidity and Mortality Weekly Report. They explain that cough and cold medications should be used with caution with children under two years of age as they can be harmful. It is noted that infant death from the toxic effects of the medications is rare. The CDC also explains that there is little evidence as to the efficacy of these drugs in children under two years of age.
In addition to the CDC’s recent warning, public health officials have taken steps to improve the safety of cough and cold medications. In 2006, the Food and Drug Administration took action to stop the manufacture of carbinoxamine-containing medications that had not been approved by the agency. Also, the 2006 Combat Methamphetamine Epidemic Act banned over-the-counter sales of cold and cough medication containing pseudoephedrine. Although this type of medication can still be purchased behind the pharmacy counter in limited quantities, pseudoephedrine has been removed from many cough and cold medications and replaced with other nasal decongestants to facilitate their over-the-counter sales.