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FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers
Date:5/17/2011

with their physicians before giving medication to younger children, especially those under the age of 3 months, Frattarelli said. Fevers of more than 100.4 degrees need to be taken very seriously in infants, whose immune systems are not fully developed and whose vaccinations haven't yet fully kicked in, he explained.

The AAP will also recommend dosing instructions be given in the milliliters, a more precise measurement than teaspoons. "A lot of parents think they can open the silverware drawer and take out a spoon, but that's not a good way to do it," Frattarelli said.

In addition, the AAP will request that acetaminophen only be sold in products marketed to children in "single-agent" formulations, rather than products that contain acetaminophen and other drugs. That would help avoid parents unwittingly giving a double dose of acetaminophen because they've given their child say, a cough medication that also contains acetaminophen and Children's Tylenol on top of that.

Earlier this month, the Consumer Healthcare Products Association, a trade association for over-the-counter drug-makers, agreed to sell only one concentration of acetaminophen in products for infant and children to prevent dosing errors.

Previously, for example, Infant's Tylenol liquid drops were much more concentrated than Children's Tylenol, which could easily lead to confusion if parents didn't read the label or know there was a difference.

Drug-makers agreed to phase out the infant drops concentration starting in the middle of this year.

In any given week, about 23 percent of kids under age 2 are given acetaminophen, according to background information from McNeil.

"Acetaminophen dosing errors are a rare but potentially very severe adverse event that could lead to liver failure or even death for kids," said Dr. Richard Dart, president of the American Association of Poison Control Centers, in a news release. "This decision will lessen the chance that paren
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