FDA Panel Backs New Dosing Guidelines for Children’s Acetaminophen

We recently wrote that the U.S. Food and Drug Administration (FDA) was looking into adding dosing instructions on over the counter (OTC) children’s medications containing <"http://www.yourlawyer.com/topics/overview/Acetaminophen-Liver-Damage-Injury-Failure-Lawsuit-Lawyer">acetaminophen. Today, dosing instructions are not provided for these medications meant for children under the age of two, an issue over which many believe is linked to the rise in acetaminophen overdosing in children. Now, said the Associated Press (AP), a panel of FDA adviser voted overwhelmingly for adding doses to acetaminophen formulas such as Children’s Tylenol, for children from six months to two years of age.

In a two-day meeting organized to discuss potential changes to ease use of the drug, the FDA panel voted 21-to-0 in favor of adding dosing details to children’s acetaminophen medications, said the AP. While the FDA is not required to follow panel advise, it historically tends to act on the side of panel findings.

Of note, pointed out the AP, dosing information was intentionally omitted to prompt parents and caretakers to visit a physician when infants and young children are ill, due, in part, because fever in younger children can be a sign of significant infection illnesses such as meningitis and pneumonia. But, the FDA panel pointed out that this omission can lead to misunderstandings on how to dose the pain relievers and fever reducers, resulting in incorrect dosing of this vulnerable demographic, said the AP. As we’ve long written and the AP noted, overdoses of these potent acetaminophen medications are prevalent in very young children and are on the rise, according to FDA information.

Yesterday’s meeting focused on a limited group of “single-ingredient” acetaminophen products such as Johnson & Johnson’s Children and Infants’ <"http://www.yourlawyer.com/topics/overview/Tylenol-Liver-Damage-Injury-Lawsuit-Lawyer">Tylenol, Novartis’ Triaminic, Prestige Brands’ Little Fevers, and a number of drugstore brand versions of the medicine, said the AP.

In another vote yesterday, the panel voted unanimously that medicines must contain dosing details based on a child’s weight, said the AP, pointing out that weight is considered the most precise way in which to determine dose amounts. While most OTC medications include dosing tables with age and weight, the FDA panel said information must state that weight is the preferred method, said the AP.

Additional recommendations included that cup measurements be limited to milliliters. Current product dosing cups can contain information in teaspoon and milliliter marks, which can confuse consumers, wrote the AP. Recommendations must “give parents and caregivers more accurate and detailed dosing information where it is needed—directly on the drug facts label,” said the Consumer Healthcare Products Association in a statement, quoted the AP.

A prior FDA panel, which convened in 2009, spoke with parents and physicians and learned that the key reason children were suffering from acetaminophen overdoses was due to their parents’ confusion on how to dose the medications, said Scott Furness, PhD, director of the FDA’s Division of Nonprescription Regulation Development, in a letter to advisory committee members, said MedPageToday recently.

In 2009, 38,500 patients were hospitalized for acetaminophen poisoning; 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 reports, according to an FDA report.

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