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New Dosing Instructions Recommended for Infant's, Children's Acetaminophen

May 19, 2011 | Parker Waichman LLP

A Food & Drug Administration (FDA) advisory panel has unanimously recommended that labeling for children's versions of Tylenol and other over-the-counter acetaminophen  include specific dosage instructions for infants and children under 2. Currently, such labels advise parents to consult a doctor about treating children under 2 with acetaminophen.

The FDA's Nonprescription Drugs Advisory Committee and its Pediatric Advisory Committee was convened for  a two-day meeting to take a look at labeling requirements for children's acetaminophen.  Acetaminophen-related overdoses have increased in recent years, especially in children under 2.  According to a report from, 38,500 patients were hospitalized for acetaminophen poisoning in 2009. Infants up to one year of age made up one percent and children from two to six years of age made up two percent of all the reported acetaminophen overdoses.  Overuse of acetaminophen can cause liver damage.

Yesterday’s advisory panel meeting looked at single-ingredient acetaminophen products, which includes Children and Infants’ Tylenol, Triaminic, Little Fevers, and store brands. The advisory panel voted d 21-0 in favor of adding doses for children 6 months to 2 years old to children’s acetaminophen formulas.   According to the Associated Press, the FDA has been mulling such changes since the 1990s.

“It’s 16 years later, and we still don’t have a clear and effective label for this product,’’  Amy Celento, the panel’s patient representative, told the panel yesterday before it took its vote. “This is taking far too long — we can’t go the way of offshore drilling and wait until a disaster before we make necessary changes.’’

According to The Wall Street Journal, the same panel also recommended that pediatric doses of acetaminophen be based first on a child's weight, then on age.  Right now, dosing is only based on age.  It also recommended that any age-associated weight tables be updated to reflect the increase in the average weight of children over the past two decades.

Other recommendations made by the panel included changing bottles for liquid acetaminophen to make it harder for kids to take an accidental overdose; require that liquids come with a measuring device clearly marked in milliliters using the standard "mL" abbreviation; and require pill forms of the drug to be sold in one concentration.

Infant versions of acetaminophen are more concentrated than children's versions. According to The Wall Street Journal, some fatal overdoses have occurred because parents used the more-concentrated infant drops in amounts meant for older children.

According to WebMD, the panel had previously recommended that liquid versions of acetaminophen be sold in only one concentration. Earlier this month, some drug makers, including Tylenol manufacturer Johnson & Johnson, voluntarily decided to stop selling the more concentrated infant liquids, and market only one concentration of acetaminophen for both infants and children.

It is not clear when the FDA will make a decision on whether or not to implement any of these recommendations. The FDA is not legally required to adopt the recommendations of its advisory panels, but does so in most cases.

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