FDA Eyes Infant Tylenol

Tuesday, May 17, 2011 - 9:11am

New dosing instructions are being considered.


Advisors to the food and drug administration will meet Tuesday to discuss how to make certain pain relievers safer for babies and children.

Government advisors are poised to address two problems when it comes to getting pain relief to sick young children.

"Either the parents don't have the right information for how to dose it, and so they guess, or they measure it wrong," said daniel Frattarelli, MD of the American Academy of Pediatrics Committee on Drugs.

The label on infant Tylenol and other over-the-counter products that contain acetaminophen says only to "consult a doctor" for kids under age 2.

An FDA panel of experts will consider whether they have enough information to add dosing instructions for children between the ages of 6 months and 2 years.

Also on the committee's agenda is whether to change dosing guidance and base it on a child's weight, rather than age.

The American Academy of Pediatrics says a change is needed because there's too much variability in how much children of a certain age weigh.

"The larger child who's given the same dose as a smaller child may not get as much effect of the drug because he's not getting as much as his body needs," said Frattarelli.

And smaller children have a higher risk of an overdose if they get too much acetaminophen.

The instructions may also be switched to milliliters so medicine will have to be measured out using dosing devices included in the packaging.

Right now, measurements of "teaspoons" are often used.

Accurate measurements, and dosing clarity, may help keep kids safe and feel better, sooner.

Comments News Comments

Post new Comment