SILVER SPRING, Maryland - federal health experts said Wednesday that dosing instructions for children under the age of 2 years old should be added to children Tylenol and similar products containing acetaminophen, reducing fever and popular pain reliever.
A panel of advisers to the Food and Drug Administration voted 21-0 for adding doses for children from 6 months to 2 years to over-the-counter acetaminophen formulas. The FDA convened a meeting of two days to take into account the changes that will make it safer and easier to use formulas.
Liquid formulas have never contained dosage information for children of less than 2 to avoid an overdose and to encourage parents to get medical care for sick children. Fever in children aged 6 months may be associated with dangerous infections such as meningitis and pneumonia.
Members of the panel of the FDA, said the lack of information contributes to the confusion and can lead to dose incorrectly children, parents. Acetaminophen overdose are more common in children under the age of 2 and have increased over the past ten years, according to data from the FDA.
Acetaminophen is especially widely used in the United States, sold drugs in hundreds of formulations and associations with other ingredients. Meeting on Wednesday with a small group of products single ingredient, including J & J child and baby Tylenol, Novartis Triaminic, little fevers of Prestige brands and various brands of Pharmacy
While safe when used as directed, acetaminophen has long been submitted to warning labels, because it can cause damage to the liver when the overallocation. Determination of errors with the products of acetaminophen children represented 2.8 per cent, or 7 500, emergency 270,165 indicated in poison control last year, according to the American Association of Poison Control centres centres.
Overdoses can be caused by parents unable to read the label, misinterpreting the dosage instructions or with a spoon or other container instead of the Cup included with the product.
Support for the FDA panelists and the efforts of the manufacturer to improve the labelling of products, but some noted that the proposed amendments have been discussed at the meetings of the FDA since the mid-1990s.
"There are 16 years later, and we still do not have a clear and effective label for this product, said Amy Celento, representative of the group." "" It takes much too long - we do not follow the example of offshore drilling and wait for a disaster before make us the necessary changes. ?
FDA is not required to follow the recommendations of its advisory panels, although it often does. The FDA will use the discussion of this week to write restrictive guidelines for cash.
In a separate vote Wednesday, the Committee voted unanimously that drugs should include dosage information based on the weight of the children, which is considered far more precise dosage. Almost all prescription drugs manufacturers already include a determination table with the weight and age. But the panelists said instructions should emphasize that the weight is the preferred approach.
Among the other changes recommended by the Committee, the limiting measures Cup millilitres. Several sections now contain trademarks spoonful tea / milliliter, said panelists may cause confusion.
The Consumer Healthcare Products Association said in a statement after the Panel that he supported the recommendations of "give parents and caregivers dosage information more accurate and detailed where it is necessary - directly on the drug facts label here.
A day earlier the Group introduced voluntary measures it has taken to take medication for children safer and easier to use. Member companies include J & J, Novartis, GlaxoSmithKline PLC and drug manufacturers generic acetaminophen as Perrigo Co.
Earlier this month, the Group announced that it will voluntarily eliminate infant acetaminophen drugs drops. For decades, industry marketed high dose of infant formula, usually delivered with a pipette, so that parents could give babies a more small amount of liquid. But from this year manufacturers later will switch all infant formulas in the same dosage used in child acetaminophen products.
In its final vote, the Group recommended 17-3, with 1 abstention, the FDA to consider mandating a single dose of acetaminophen solid for children.
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