WEDNESDAY, May 18 (HealthDay News) -- U.S. health advisers
recommended Wednesday that dosing instructions should be added to
the labels of medicines containing the widely used pain reliever
and fever reducer acetaminophen to better protect children under
the age of 2.
In a 21-0 vote, the panel of U.S. Food and Drug Administration
advisers called for adding dosing information for children 6 months
to 2 years old to over-the-counter medicines such as Children's
Tylenol and similar products containing acetaminophen, the
Associated Press reported.
Currently, the labels of such medications have dosing
instructions for children aged 2 and up. For kids under 2, the
labels on the liquid medicines simply tell parents to "ask a
The FDA advisers said the lack of specific dosing
recommendations can lead to confusion, with parents unintentionally
giving too much of the medicine to children under age 2.
Acetaminophen-related overdoses are most common among children
younger than 2, and have increased over the past decade, according
to FDA data.
Wednesday's vote focused only on a small group of
single-ingredient products, including J&J's Children and
Infants' Tylenol, Novartis' Triaminic, Prestige Brands' Little
Fevers and assorted drugstore brands, the
In a second vote Wednesday, the panel recommended unanimously
that these medicines should also include dosing information based
on children's weight -- considered the most accurate way to
determine the proper dose. Nearly all over-the-counter
manufacturers already include a dosing table with both weight and
age. But the FDA advisers said instructions must emphasize that
weight is the preferred approach, the
In a third vote, the advisers recommended 17-3, with one
abstention, that the FDA consider requiring a single dosage for
children's solid acetaminophen tablets, the news service said.
While the FDA is not required to follow the recommendations of
its advisory panels, it usually does so.
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 planned to testify before the joint, two-day meeting of the FDA's 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 called 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.
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 infants 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."
U.S. Food and Drug Administration has more on
giving over-the-counter medications to children.