-January 12, 2007
Over-the-counter cold medications can have potentially deadly effects in children under the age of 2, according to a new government report.
The report cited three infant deaths in 2005 and more than 1,500 emergency room visits over the course of a year for treating problems related to the use of cough and cold medications in very young children.
Investigation into Infant Deaths
Officials at the Centers for Disease Control and Prevention and the National Association of Medical Examiners looked into the deaths of the three infants and found that all three deaths were caused by cough and cold medications.
The babies two male and one female between the ages of 1 and 6 months all received doses of pseudoephedrine (a nasal decongestant) nine to 14 times greater than that recommended for children between the ages of 2 and 12.
Two of the infants had also been given medications containing the antihistamine carbinoxamine. Detectable levels of acetaminophen and the cough suppressant dextromethorphan were additionally found in two of the babies.
Cough and cold medications can be harmful, and even fatal, and should be used with caution in children under 2 years of age, said Dr. Adam Cohen, study author and officer in the Epidemic Intelligence Service at the CDC.
Government Action
In March 2006, the Combat Methamphetamine Act was passed, banning the over-the-counter sale of products containing pseudoephedrine. Cough and cold medications containing the ingredient are now only available behind-the-counter.
Several months later in June, the FDA forced manufacturers to halt the production of medications containing the antihistamine carbinoxamine, which included labeling for use in young children and infants. However, some of those products might still be on the shelves.
No Benefit
Cough and cold medications, especially medications containing pseudoephedrine have never been shown to have any beneficial effect on children less than 2 years of age, yet they clearly can have significant harmful effects, said Dr. Michael Marcus at the Maimonides Infants & Children’s Hospital in New York City.
The Food and Drug Administration has not approved over-the-counter cough and cold medications for very young children because studies have shown that they offer no benefit over a placebo. Consequently, appropriate dosage amounts remain unknown.
Many over-the-counter medicines may be marketed for infants, and there are no approved dosing recommendations from the FDA for this age group. There’s very little evidence that they help in children under 2, said Dr. Cohen.
Advice for Parents
Parents are urged to avoid giving their children over-the-counter medications unless first consulting with a pediatrician or other healthcare provider. Some experts suggest that parents stay away from cough and cold medications altogether.
There are no studies to support the use of cold medicine in infants. The thing to keep in mind is that colds go away. Kids might benefit from a humidifier by the bed and saline nose drops, but this kind of loving care is all most kids need, said Dr. Gwen Wurm at the University of Miami Miller School of Medicine.
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