FDA Panel Looks to Prevent Drug Error by Changing Children’s Acetaminophen Product Labels

In recent pharmacy error injury news that our Hartford County, Maryland attorneys have been following, a panel advising the U.S. Food and Drug Administration (FDA) has recommended that dosing instructions for children’s acetaminophen be based primarily on a child’s weight and not age, and be changed to include children under two years—to reduce the risk of medication error.

According to the Wall Street Journal (WSJ), a majority of dosing information for over-the-counter (OTC) children’s medicine containing acetaminophen have instructions based on age, with only some information on dosing by weight, causing confusion in dosing that could lead to error or injury. Acetaminophen is the most commonly used OTC medication to lower fevers in children and relieve pain, with the best-known brand being Children’s Tylenol.

The federal advisory panel has recently recommended that all acetaminophen products should contain a standard label with updated weight tables to reflect average weight increase among children over the past 20 years.

According to the FDA reports from 2000 to 2010, there were 14 fatalities and 74 non-fatal adverse events that were related to acetaminophen drug errors in infants and children from the age of 13 and younger. Some of the medication error fatalities were due to incorrect usage of the more-concentrated infant drops that were meant for older children, but used on infants.

The FDA panel reportedly recommended a single infant and children’s medication formula in 2009 that is slated for release this summer. The panel also recommends that the FDA should consider a single concentration of acetaminophen in solid forms, to avoid possible drug errors or overdoses with children.. The panel also voted to add dosage instructions for children from six months to two years onto liquid products. Currently on acetaminophen formulations for children, the dosing information is for children from 2-12 years old, with instructions to contact your doctor for children under 2 years.

Panel Calls for Label Changes on Acetaminophen Products, WSJ, May 19, 2011
Clearer kids’ dosing urged for acetaminophen-containing meds, CNN, May 18, 2011

Related Web Resources:

U.S. Food and Drug Administration: Medication Error Reports

Institute for Safe Medication Practices, (ISMP)

20 Tips to Help Prevent Medical Errors in Children: Patient Fact Sheet, Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services

Related Blog Posts:

Prescription Error Overdose Leads to Paralysis, Victim Hopeful for Recovery, Pharmacy Error Injury Lawyer Blog, May 19, 2011
FDA Redesigns Pharmacy Packet Inserts to Avoid Medication Error Injury, Pharmacy Error Injury Lawyer Blog, May 9, 2011
AHRQ Tips for Preventing Medical Mistakes with Children, Pharmacy Error Injury Lawyer Blog, March 30, 2010

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