FDA Panel Recommends Dosage Instructions for Infants Receiving Children’s Tylenol

A panel of Food and Drug Administration advisers voted 21-0 in favor of adding doses for children 6 months to 2 years old to over-the-counter acetaminophen formulas. The FDA has convened a two-day meeting to consider changes that will make the formulas safer and easier to use.

The liquid formulas have never contained dosing information for children under 2 to avoid an overdose and to encourage parents to seek medical attention for sick infants. Fever in children younger than six months can be associated with dangerous infections, like meningitis pneumonia, and Kawasaki disease.

The FDA’s panelists said the lack of information contributes to confusion and can lead parents to incorrectly dose children. Acetaminophen-related overdoses are most common among children younger than 2, and have increased over the past decade, according to FDA data.

Acetaminophen is among the mostly widely used drugs in the U.S., sold in hundreds of formulations and combinations with other ingredients. Wednesday’s meeting dealt with a small group of single-ingredient products, including J&J’s Children and Infants’ Tylenol, Novartis’ Triaminic, Prestige Brands’ Little Fevers and various drugstore brands
While safe when used as directed, acetaminophen has long been subject to warning labels because it can cause liver damage when overused. Dosing errors with children’s acetaminophen products accounted for 2.8 percent, or 7,500, of the 270,165 emergencies reported to poison centers last year, according to the American Association of Poison Control Centers.
Overdoses can be caused by parents not reading the label, misinterpreting the dosing instructions or using a spoon or other container instead of the cup included with the product.

The FDA will use this week’s discussion to write binding guidelines for drugmakers.
In a separate vote Wednesday, the panel voted unanimously that medicines should include dosing information based on children’s weight, which is considered the most accurate dosing measure. Nearly all over-the-counter manufacturers already include a dosing table with both weight and age. But panelists said instructions must emphasize that weight is the preferred approach.

I represented a young boy in a Medical Malpractice claim because his pediatrician failed to diagnose Kawasaki Disease, which is a rare condition in children that involves inflammation of the blood vessels.

Kawasaki disease often begins with a high and persistent fever greater than 102 °F, often as high as 104 °F. A persistent fever lasting at least 5 days is considered a classic sign. The fever may last for up to 2 weeks and does not usually go away with normal doses of acetaminophen (Tylenol) or ibuprofen.

In our particular case, the parents took the boy to the doctor on the first day of fever, and the pediatrician kept prescribing tylenol. The boy’s fever would vary with the Tylenol, but was persistent for a period of weeks. Ultimately a specialist was called and the diagnosis was made. Thus, even though the Tylenol did not have dosage instructions, the pediatrician prescribed the dosage and ignored all the other symptoms that the child had. Thus, the risk that parents will not take their children to a doctor would seem minimal at best. Specifically because Tylenol will not take away the symptoms or fever, but will only reduce them for a brief duration.