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Panel backs dosing instructions for acetaminophen
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An FDA advisory committee voted today to recommend dosing instructions on products containing acetaminophen, specifically dosing instructions for children aged younger than 2 years.
The panel also voted 17-3 in favor of dosing strengths for solid forms of acetaminophen based on children’s weight and 16-5 against adding labeling that these products provide an analgesic benefit.
The committee made the recommendations after about a day and a half of meetings, during which they heard about accidental overdoses of acetaminophen. Dosing of products such as Johnson & Johnson’s Children and Infants’ Tylenol, Novartis’ Triaminic and other brands has been confusing, panel members said, because these products have never contained dosing information for children aged younger than 2 years.
The panel said over-the-counter sales of products containing acetaminophen increased about 40% between 2001 and 2009. About 60% of these products are combination products, and 42% contain a single ingredient. The panel heard data that suggested some parents have administered the single-ingredient product, as well as the combination, when they were unaware that the combination contained both.
Panel members said labeling appears to be an issue for some caregivers because these labels are frequently not clear enough, or they are written in more than one language.
The panel said there were 40,000 hospitalizations related to accidental acetaminophen overdosing in 2009 alone, adding that many of these incidents occurred in children aged younger than 2 years.
The panel stressed the importance of educating the public about safely using acetaminophen products. They also urged health care providers to remain aware of the signs and symptoms of acetaminophen toxicity.
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