A Critical Review of: “Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications”

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Ran D. Goldman




Millions of children around the world use over the counter (OTC) cough and cold preparations every year. Previous reports associated some of the preparations with severe toxicity and even death, especially in very young children (under 2 years old). While some expert groups recommended restrictions for the use of these medications, and actions of the Food and Drug Administration in the US upon these recommendations, the use of such cough and cold preparations is widespread.

In this study a group of pediatricians and toxicologists from several centers in the US sit on an expert panel to look at reported incidents of death and to determine - what was the potential relationship between the use of cough and cold preparations and the child’s death.

All cases of death among children under 12 years old, documented in five different sources of information, including the medical literature, FDA databases and manufacturers’ reports that mentioned a cough and cold ingredient were abstracted.

The experts found that of 189 cases, 118 were judged possibly, likely, or definitely related to a cough and cold ingredient. Of the latter, 103 involved a nonprescription drug and of these 88 involved an overdose. The authors identified that age younger than 2 years, use of the medication for sedation, use in a daycare setting, combining two or more medications with the same ingredient, failure to use a measuring device, product misidentification, and use of products intended for adults were associated with the fatalities. Finally, the review of the information showed that six of the children died after an attempt to sedate them; three were cases of abuse; and in 10 cases homicide was suspected.

Abstract 55 | PDF Downloads 27


1. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01899.html
2. http://www.hc-sc.gc.ca/ahcasc/media/advisories-avis/_2008/2008_184-eng.php