Over-the-counter cough and cold medications can be harmful -- even deadly -- to very young children, U.S. government research shows.
In 2005, three infants under the age of 6 months died from taking such medications. And, from 2004 to 2005, more than 1,500 children under the age of 2 were treated in emergency rooms for problems related to taking such medications, according to a report released Thursday.
"Cough and cold medicines can be harmful, and even fatal, and should be used with caution in children under 2 years of age," said study author Dr. Adam Cohen, an officer in the Epidemic Intelligence Service at the U.S. Centers for Disease Control and Prevention. "They are drugs, so they have risks as well as benefits."
The study appears in the Jan. 12 issue of the Morbidity and Mortality Weekly Report, a publication of the CDC.
The U.S. Food and Drug Administration has only approved the use of over-the-counter cough and cold medicines in children over the age of 2. In children younger than 2, studies have concluded that such medications are no more effective than a placebo. As a result, appropriate dosing is not known.
"Cold and cough medications, especially medications containing pseudoephedrine [a nasal decongestant], 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, director of pediatric pulmonology, allergy and immunology at the Maimonides Infants & Children's Hospital in New York City.
"There are no studies to support the use of cold medicine in infants," said Dr. Gwen Wurm, director of community pediatrics at the University of Miami Miller School of Medicine. "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."
Various professional groups, including the American Academy of Pediatrics and the American College of Chest Physicians, have issued guidelines recommending caution when using these medications in young children.
In June 2006, the FDA took action to stop the manufacture of medications containing carbinoxamine (an antihistamine) which were inappropriately labeled for use in infants and young children. Manufacturers were required to stop production by Sept. 6, 2006, but some products might still be in distribution.
The Combat Methamphetamine Epidemic Act of 2006, passed last March, banned over-the-counter (though not behind-the-counter) sales of products containing pseudoephedrine. As a result, many companies have taken this ingredient out of their products.
But products which might be harmful to young children are still available, so officials at the CDC and the National Association of Medical Examiners (NAME) investigated deaths of children under the age of 1 that were associated with cough and cold medicines.
The three infants who died ranged in age from 1 to 6 months; two were male and all three were found dead in their homes.
Autopsy and medication investigation records revealed that cough and cold medications were responsible for all three deaths. All three babies had high levels of pseudoephedrine, ranging from nine to 14 times the levels expected from recommended doses for children aged 2 to 12. One of the infants had received both a prescription and an over-the-counter cough and cold medicine at the same time, both of which contained pseudoephedrine.
Two of the children had taken prescription medications containing carbinoxamine, although there were no detectable blood levels of the substance. Two of the infants had detectable blood levels of dextromethorphan (a cough suppressant) and acetaminophen (a fever-reducer and analgesic).
"Parents should absolutely avoid these medications unless they are being supervised by a physician," Marcus said. "Parents should realize that non-prescription medications may contain similar products to medications that the pediatrician is also prescribing, therefore, they should let the pediatrician know all treatments the child is receiving when discussing a child's treatment."
"Parents should never give medicine without consulting a health-care provider, even over-the-counter," Cohen added. "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."