FDA Panels to Weigh Dosing Labels for Kids' OTC Fever
TUESDAY, May 17 (HealthDay News) -- 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
"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.
Drug makers, including McNeil Consumer Healthcare, which makes
Tylenol, also support the change.
"McNeil is committed to encouraging the appropriate and safe use of medicines in children, including adding new dosing information on the OTC pediatric acetaminophen label to assist caregivers and health-care providers in appropriately dosing children, especially those 6 to 23 months of age," the company wrote in materials submitted to the FDA.
By way of comparison, drugs containing ibuprofen -- another
heavily used over-the-counter fever reducer -- already include
dosing information for children under age 2.
Children's medications containing acetaminophen have been sold
over-the-counter since 1959, and dosing information for children
has been on the labels since the 1970s, according to McNeil.
Back then, doses for kids were somewhat crude -- children 12 and
up were advised to take the adult dose, kids 6 to 12 were told to
take half that, and kids younger than 6 were told to take a quarter
of the adult dose.
Since then, as physicians have learned more about the
medications, dosing recommendations for infants and toddlers have
become more refined and now should be based on weight, not age,
according to the AAP. (Age is still listed on package labeling, the
AAP explained.) Kids' weights can range widely at any given age, so
the correct dose for a child on the heavier side may not be the
correct dose for a smaller child of the same age.
Though acetaminophen is safe even in newborns if used correctly,
the drug makers and the AAP are calling for expanding the labeling
information for children 6 months old and up.
Parents should still be encouraged to consult 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
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
"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 parents will give their children the wrong dose."
At the hearing, the FDA will also consider adding a weight-based
dosing regimen to the existing age-based dosing regimen for kids 2
to 12 and to make it mandatory to include a universal measuring
tool with all children's formulas.
U.S. Food and Drug Administration has more on
giving over-the-counter medications to children.
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