Lower Acetaminophen Doses Recommended Despite Cost Impact, Lack Of Data
This article was originally published in The Tan Sheet
A joint advisory committee recommended as a "top priority" that FDA lower the maximum single and daily dose of acetaminophen, despite inconclusive data that the current dose poses significant hepatotoxicity risks
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McNeil Consumer Healthcare lowers the maximum daily dose indicated on labels of Extra Strength Tylenol, the first in a series of dosing changes for the firm’s acetaminophen-containing products.
FDA is asking a joint advisory panel to consider whether it should restrict firms to one standard acetaminophen concentration for all solid oral dosage single-ingredient pediatric products, among other measures to reduce dosing errors.
Over-the-counter drug firms will make single-ingredient liquid acetaminophen pediatric products only in one standard concentration to help prevent dosing errors, their trade association said May 4.