May 18, 2011

Dosing Instructions For Kids Under 2 Should Be Added To Tylenol

Federal health experts said on Wednesday that dosing instructions for children younger than 2-years-old should be added to Children's Tylenol and similar products containing acetaminophen, according to an Associated Press report.

A panel of Food and Drug Administration (FDA) advisers voted 21-0 in favor of adding doses for children 6 months to 2-years-old to over-the-counter acetaminophen formulas.  The FDA is holding a two-day meeting to consider changes that will make the formulas safe and easier to use.

The liquid formulas never contained dosing information for children under 2 to avoid an overdose and to encourage parents to seek medical attention for sick infants.

Fever in children younger than six months can be associated with infections like meningitis and pneumonia.

The FDA's panelists said the lack of information contributes to confusion and can lead parents to incorrectly dose children.

According to FDA data, acetaminophen-related overdoses are most common among children younger than 2 and have increased over the past decade.

Wednesday's meeting dealt with a small group of single-ingredient products, including J&J's Children and Infants' Tylenol, Novartis' Triaminic, Prestige Brands' Little Fever and various drugstore brands.

Acetaminophen, one of the most widely used drugs in the U.S., has been the subject of debate over warning labels because it can cause liver damage when overused.

According to the American Association of Poison Control Centers, dosing errors with children's acetaminophen products accounted for 2.8 percent, or 7,500, of the 270,165 emergencies reported to poison centers last year.

Overdoses can be caused by parents not reading the label, misinterpreting the dosing instructions or using a spoon or other container instead of the cup included with the product.

Panelists supported the FDA and manufacturer's efforts to improve abetting for the products.

However, some pointed out that the proposed changes have been discussed at FDA meetings since the mid-1990s.

"It's 16 years later, and we still don't have a clear and effective label for this product," Amy Celento, the panel's patient representative, said in a statement. "This is taking far too long "” we can't go the way of offshore drilling and wait until a disaster before we make necessary changes."

The FDA will use this week's discussion to write binding guidelines for drugmakers.

The panel unanimously voted on Wednesday that medicines should include dosing information based on children's weight, which is considered the most accurate dosing measure.

Nearly all over-the-counter manufacturers already include a dosing table with both weight and age.  However, panelists said instructions should emphasize that weight is the preferred method.

The Consumer Healthcare Products Association presented voluntary steps on Tuesday that it has taken to make children's medicines safer and easier to use. 

The group announced earlier this month that it would voluntarily eliminate infant drops of acetaminophen drugs.
The panel recommend in a final vote that the FDA should consider mandating a single dosage for children's solid acetaminophen tablets.


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