Dosage changes making acetaminophen safer for children

August 11, 2011

Telling parents to have their children take 2 Tylenol and call you in the morning may soon be safer than ever. The FDA is asking drug makers to voluntarily adopt recommendations to make children?s medicines containing acetaminophen safer to use. The industry has complied, phasing out some formulations and changing dosage recommendations. Find out what will now be available.

Telling parents to have their children take 2 Tylenol and call you in the morning may soon be safer than ever.

The US Food and Drug Administration (FDA) is asking drug makers to voluntarily adopt recommendations to make children’s medicines containing acetaminophen safer to use.

Among their recommendations is that liquid, chewable, and tablet forms be made in just 1 strength. Currently, there are 7 strengths available for these forms combined.

They are also recommending that dosing instructions to reduce fever be developed for children as young as 6 months. Current instructions apply to children aged 2 to 12 years but advise only “to consult a doctor” for those under age 2.

FDA would like to see weight, not just age, be a factor in dosing instructions and that standards be set for dosing devices, such as spoons and cups, commonly used for children’s medications.

“FDA is considering these recommendations,” said Sandra Kweder, MD, deputy director of the FDA’s Office of New Drugs. She also said that it could take years to get any new regulations finalized and that voluntary compliance would more quickly improve the safety of acetaminophen.

The agency already has agreement from drug makers to phase out concentrated infant drops. In a recent consumer alert, the agency said the use of concentrated drops in larger amounts, such as giving a teaspoon to an older child, could lead to fatal overdoses.

The FDA also is urging health professionals to spell out the word acetaminophen in any prescription so that parents will know not to give their children more than 1 formulation at a time.

Recently announced changes in dosage will affect teenagers and other older children who use adult formulations of acetaminophen as well.

The manufacturers of Extra Strength Tylenol are lowering the maximum daily dose from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg) and the interval from 2 pills every 4 to 6 hours to 2 pills every 6 hours.

The new dosing label, which will begin appearing on products in the fall, is an effort to reduce the risks of acetaminophen overdose, a leading cause of liver failure.

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