FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers

Two U.S. Food and Drug Administration advisory committees plan to meet Tuesday and Wednesday to decide whether to recommend that the dosing instructions on the labels of medicines containing acetaminophen need to be fine-tuned to protect children under the age of 2 against possible liver failure and even death. Currently, the labels of such fever-reducing medications, which include Children's Tylenol, have dosing instructions for children aged 2 and up. For kids under 2, the labels simply tell parents to "ask a doctor." The American Academy of Pediatrics (AAP) and drug manufacturers are both strongly in favor of giving parents the additional dosing information.

"If we give parents better information, they will be able to give enough of the medicine to work well, at the same time minimizing the side effects," said Dr. Daniel Frattarelli, a pediatrician in Dearborn, Mich. who chairs the academy's drug committee and who plans to testify before a joint, two-day meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee. "Parents want to do the right thing for their children," he said. "We as a medical community have to give them that information so they are able to do this." Although the evidence shows that acetaminophen is safe for young children, parents have to be careful with it, pediatricians noted. Giving too much can be toxic to the liver, causing poisoning and even liver failure.

In 2010, there were 270,000 reported overdoses of acetaminophen, according to the American Association of Poison Control Centers. Dosing errors involving children's acetaminophen products accounted for almost 7,500 cases nearly 3 percent. In an ideal world, the parents of infants and toddlers would still consult with their pediatrician or pharmacist to get the proper medication dosing, said Dr. William Basco, director of general pediatrics at the Medical University of South Carolina. But the reality is that many parents aren't doing that and are instead guessing about proper dosing. "There is no benefit to having parents guess at the right dose," Basco said.