At least 10 infant deaths in Arizona in 2006 were linked to over-the-counter cough and cold remedies - underscoring the danger of giving the medications to children younger than 2, researchers report.

The investigators found that of 21 infants who died unexpectedly and had autopsy data available, 10 had evidence that they been given cough or cold medication shortly before they died.

The findings, published in the journal Pediatrics, do not prove that the medications caused or contributed to the infants’ deaths, but they add weight to a recent warning from the Food and Drug Administration (FDA) that parents not give cough and cold remedies to children younger than 2.

“We strongly recommend that parents not use these medications,” said Dr. Mary Ellen Rimsza of the University of Arizona College of Medicine in Tucson, the lead researcher on the new study.

Cold and cough medications typically contain a combination of decongestants, antihistamines and cough suppressants - all of which can have serious side effects in young children, including increased blood pressure, heart rate disturbance, and depressed breathing.

While these dangers are now recognized, until now no study had examined the possible role of cough and cold medications in unexplained infant deaths.

Rimsza and colleague Susan Newberry base their findings on data routinely collected by the state of Arizona on child deaths. In 2006, there were 90 unexpected infant deaths, including 42 that were attributed to an injury or suffocation. The researchers focused on the remaining 48 deaths, of which 21 had autopsy data.

Of those 21 cases, the researchers found, toxicology reports showed evidence that 10 infants had been given cough and cold medication soon before their deaths.

However, only one death had actually been attributed to cough and cold medication; “respiratory illness” was listed as the cause of death in six cases, while sudden infant death syndrome was blamed in another two.

Whether the medications led to any of these deaths is unclear, but the bottom line for parents remains the same, Rimsza told Reuters Health: Don’t give the drugs to infants.

There are also concerns about the safety of cold and cough remedies for older children.

In fact, an expert advisory panel to the FDA has recommended that parents refrain from giving the medications to children younger than 6. The FDA is still reviewing the data on that question.

Rimsza told Reuters Health that as a pediatrician, she agrees with the stance of the advisory panel. Parents may assume that over-the-counter means “safe,” she noted, but in fact, cough and cold medications have never been proven safe and effective for children of any age.

SOURCE: Pediatrics, August 2008.