January 12, 2007
ATLANTA — More than 1,500 toddlers and babies wound up in
emergency rooms over a two-year period and three died because of bad
reactions to cold or cough medicine, federal health officials reported
Thursday.
The U.S.
Centers for Disease Control and Prevention warned parents
not to give common over-the-counter cold remedies to children under 2
years old without consulting a doctor.
The deaths of three infants 6 months or younger in 2005 led to an
investigation that showed the children all had high levels of the
nasal decongestant
pseudoephedrine, up to 14 times the amount recommended for
children ages 2 to 12. The study found 1,519 ER cases from 2004 and
2005 involving young children and cold medicine.
The CDC said it's not known how much cold or cough medicine can
cause illness or death in children under 2 years old, but there are no
approved dosing recommendations by the U.S. Food and Drug
Administration for that age group.
The American Academy of Pediatrics first advised parents in 1997
about the risks of complications and overdose potential with certain
cough suppressants. Last year the American College of Chest Physicians
advised doctors not to recommend cough suppressants and
over-the-counter cough medications to young children because of the
risks.
The new labeling also will clarify that the two drugs are
recommended for use only after other prescription topical medicines
have been tried by patients, the FDA said. The agency is also issuing
a guide updating patients of its concerns.
A black box warning is the most serious type of warning in
prescription drug labeling. The warning will be located lower on the
labels of the two drugs than is typical, although a statement higher
on the labels will refer to the risk.
Dr. Michael Shannon, chief of emergency medicine at Children's
Hospital Boston, said it's common, especially in the winter, to see
emergency room cases of toddlers given cough or cold medicine.
"Pediatricians have for years, particularly for the last five
years, been for the most part trying to dissuade parents from giving
young children common cold preparations," Shannon said.
Dr. Michael Marcus, director of pediatric pulmonology, allergy and
immunology at Maimonides Infants and Children's Hospital in New York,
said, "The best thing (parents) can do is support with fluids and lots
of kisses and time, because lots of infections are viral and will pass
in a few days. The medications have a greater potential for harm than
the infections you are trying to treat.
