Pediatric Acetaminophen Panel Debates Execution Of Dosing Changes
This article was originally published in The Pink Sheet Daily
Both weight-based dosing and the addition of instructions for children younger than 2 years have broad support from manufacturers and health care professionals as well as from FDA advisors.
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Settlement could be another milestone in the contentious history of labeling for OTC acetaminophen single-ingredient products generally, and for infant’s and children’s products specifically. Plaintiffs alleged they were misled by J&J to pay more for Infant's Tylenol even though its formulation is the same as Children's Tylenol.
Appropriators are "concerned that the lack of dosing information" on OTC drugs for children ages six months to 2 years "may lead to dosing errors, adverse events and inadequate treatment of fever and pain.” They also ask USDA about fraud in its National Organic Program.
Johnson & Johnson narrows its pediatric Tylenol tablets a single 160 mg dose and other manufacturers are expected to follow suit, in line with a US FDA panel recommendation.