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title pic FDA Advises More Stringent Dose Guidelines for Children’s Medicines Containing Acetaminophen

Posted by Fiona Cole on June 9, 2011

FDA Advises More Stringent Dose Guidelines for Children’s Medicines Containing Acetaminophen

The Food and Drug Administration has released revised guidelines regarding the labeling and dosing of medicines containing acetaminophen, a commonly-used fever reducer and pain reliever, in an attempt to better protect infants (children under the age of 2).

Currently, the labels for these over-the-counter medications, such as Children’s Tylenol, Prestige Brands’ Little Fevers and other drugstore brands, list dosing instructions for children older than 2 years. But for children under 2, the labels advise parents to “ask a doctor.” The advice coming from the FDA panel now recommends that specific dosing instructions for children aged 6 months to 2 years be included on the medicine label.

Overdoses of acetaminophen are most commonly seen in children under 2 years old and, according to the FDA, the number reported has increased during the last ten years. The FDA cites the absence of specific dosing instructions for younger children as a source of confusion, stating that this lack of guidance has led to parents unintentionally giving a higher dose of the medicine than is safe. Ideally, parents of toddlers and infants would seek advice from their doctor regarding correct dosing for younger children, but the reality is that many parents are guessing.

The FDA panel also voted for the medicine labels to include dosing instructions based on the weight of the child, which is considered to be the most accurate method for calculating the correct dose of medication. Currently, most over-the-counter medicines already include weight guidelines, but the FDA advisers have said that label instructions must now emphasize that weight-related dosing is the preferred approach.

The drug manufacturers are in support of the FDA panel’s advice. In documents submitted to the FDA, Tylenol-manufacturer McNeil Consumer Healthcare wrote, “McNeil is committed to encouraging the appropriate and safe use of medicines in children, including adding new dosing information on the OTC pediatric acetaminophen label to assist caregivers and health-care providers in appropriately dosing children, especially those 6 to 23 months of age.”

“Acetaminophen dosing errors are a rare but potentially very severe adverse event that could lead to liver failure or even death for kids,” says the president of the American Association of Poison Control Centers, Dr. Richard Dart. “This decision will lessen the chance that parents will give their children the wrong dose.”

In contrast, the labels of medicines containing ibuprofen, another widely-used over-the-counter fever reducer, already list dosing instructions for infants.

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