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Infant Cold Medicines Implicated in Deaths

Aug 7, 2008 | Parker Waichman LLP

Over-the-counter cold medicines have been linked to the deaths of 10 infants in Arizona, according to a new study published in the journal Pediatrics.   The study gives new credence to a recent Food & Drug Administration (FDA) warning that children under two should not be given over-the-counter cough and cold medicines.

In conducting the study, researchers from the University of Arizona College of Medicine in Tucson looked at 90 unexpected infant deaths that occurred in 2006.  Those fatalities included 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, 10 had evidence that they been given cough or cold medication shortly before they died.  

It is unclear what role these drugs played in the deaths.  Only  one death had actually been attributed to cough and cold medication.   Six others were blamed on respiratory distress, while SIDS was cited in two others.  Still, the researchers said that their findings are just one more indication that over-the-counter cold medicines are not appropriate for very young children.

Many parents  assume that over-the-counter means “safe," but most caregivers don't realize that cough and cold medications have never been proven safe and effective for children of any age.  In fact, 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.

Earlier this year, the FDA issued a warning advising that over-the-counter cold and cough medicines should not be given to children under two.  The warning came after a 2007 study conducted by the Centers for Disease Control found that between 2004 and 2005, 1,500 children under the age of 2 had been injured by common over-the-counter decongestants and antihistamines. A second study by FDA safety reviewers reached similar conclusions. Their research found that from 1969 to 2006, at least 54 children died after taking over the counter decongestants, and 69 died after taking over-the-counter antihistamines.

Knowing the FDA warning was coming, some drug manufacturers had already taken steps to remove their infant cold medicines from the market. The medicines recalled in October 2007 included Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand. Pediacare, Dimetapp and Little Colds brand products were also recalled.

The FDA is still reviewing the safety of similar cold medicines in children ages 2-11.  For now, many doctors advise parents to avoid use of such medications in children under 6 years old.

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