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Pediatrics

FDA Panel Urges New Instructions and Dosing on Infant Pain Relievers
Alice G. Walton

May 26, 2011

In an effort to prevent overdoses in infants and toddlers, an FDA panel has voted to include dosing instructions for babies from 6 months to 2 years on infant acetaminophen (Tylenol) labels. Current labels do not include these instructions, but instead urge parents to check with a doctor before giving the medicines to children under 2.

Though most infant pain relievers/fever reducers are considered safe to use, overdoses have occurred in certain circumstances. And because the overdoses occur more frequently in kids under 2, the lack of labeling in this age group may have an unwanted effect: rather than prompting parents to seek medical advice about dosing, the labels may be causing parents to make bad guesses about safe amounts to give their under-2 infants.

The new labels will include dosing instructions based on both weight and age, for kids 6 months-13 years, with an emphasis on weight, the more important factor in dosing.

The same panel also decided that the labels of acetaminophen products like Tylenol should not indicate that they should be used as pain relievers in children under 2 years old — only that they are effective as fever reducers. Apparently, there is not enough evidence to indicate that they actually work for pain relief in children of this age group.

The Consumer Healthcare Products Association (CHPA), which represents over-the-counter drug makers like Johnson & Johnson, Novartis and GlaxoSmithKline, recently stated that it would be making some voluntary changes to kids’ medications. Infant’s and children’s acetaminophen would now be manufactured at the same concentration to avoid confusion. They will also include safety tops ("flow restrictors") to prevent kids from consuming large amounts of the flavored products unsupervised. Measurements will now also be in milliliters (mL) only, rather than both mL and teaspoon measurements, since having both markings may add to consumer confusion. These changes will go into effect later this year.

While the CHPA said it did not support removing the pain relief indication from labels, it did support the revamping of dosing to make things clearer for parents of younger infants. They say that pediatricians will be able to make recommendations to parents about the using infant acetaminophen products as pain relievers. As always, talk to your child’s doctor about any concerns you have about the medications you give to your child, regarding their dosing or correct usage.

The FDA panel made its recommendations on May 18, 2011.