WASHINGTON - Federal health officials are considering adding dosing instructions for children younger than 2 to Children's Tylenol and similar products, a change favored by drugmakers and many doctors.
The Food and Drug Administration meets next week to consider changes to children's over-the-counter formulas containing acetaminophen, the most common pain reliever and fever reducer.
While safe when used as directed, acetaminophen has long been subject to warning labels because of its potential to cause liver damage when overused.
Next week's meeting will focus on a small group of liquid medicines, including Children and Infants' Tylenol, Triaminic, Little Fevers and various drugstore brands. These products have never contained dosing information for children younger than 2 to encourage parents to seek medical attention for sick infants. Fever in children younger than 6 months can be associated with dangerous infections, like meningitis and pneumonia.
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In documents posted Friday, the FDA said it will ask an outside panel whether that policy should be changed. An analysis by the agency showed that the majority of acetaminophen overdoses in children are in those younger than 2. FDA staffers said the most common causes for the problems include parents misreading dosing information, giving an adult formula to a child, or using a spoon or other device instead of the cup included with the formula.
The FDA will also consider requiring weight-based dosing instructions alongside age-based instructions on packaging, along with a universal measuring cup for all children's formulas. Nearly all manufacturers have already taken those steps voluntarily, but an FDA regulation would make them mandatory.
The lack of instructions for the youngest children - an FDA requirement since the 1950s - is intended to point parents toward professional advice, but some experts say it causes more confusion and stress than anything else.
"I don't know if it worked 30 years ago - I doubt it - but it certainly doesn't work today because you can't get your doctor on the phone," said Dr. Richard Dart, president of the American Association of Poison Control Centers. "It places this enormous burden on parents and caregivers because they don't know what to do."
Dosing errors with children's acetaminophen products accounted for 2.8 percent, or 7,500, of the 270,165 emergencies reported to poison centers last year, according to Dart's group.
