From Our 2011 Archives
FDA Panel: Correct Acetaminophen Dose Depends on Kids' Weight
Infant Drug Labels Should Spell Out Dose; Industry Backs New Rule
By Daniel J. DeNoon
Reviewed by Laura J. Martin, MD
May 18, 2011 -- An FDA advisory panel says that pediatric doses of acetaminophen should be based first on a child's weight, then on age.
The panel noted that infant acetaminophen -- Tylenol is the best-known brand -- should be labeled only for fever reduction in children under age 2. Labels may recommend acetaminophen for both fever and pain in children over age 2.
The panel found too little evidence to label over-the-counter acetaminophen for pain relief in infants under age 2, although doctors often prescribe the drug for this purpose.
The recommendation not to include pain as an indication for acetaminophen in kids under age 2 is the only part of the panel's advice to which the over-the-counter drug industry trade group objects. Otherwise, the Consumer Healthcare Products Association (CHPA) applauds the panel's advice.
In addition to weight-based dosing and the infant fever recommendation, the panel also advised the FDA to:
The FDA usually, but not always, follows the advice of its advisory panels.
Beating the FDA panel to the punch, the CHPA recently announced that acetaminophen makers would voluntarily convert all single-ingredient liquid acetaminophen products to a single concentration, doing away with the more concentrated infant drops that reduce the amount of liquid an infant has to swallow.
The industry also announced it would put flow restrictors on liquid acetaminophen bottles to make it hard for kids to drink large amounts of the drug in an accidental, unsupervised ingestion. Moreover, the companies will provide clearly marked syringes with all products for kids ages 3 and younger, and will add clearly marked dosing cups to all products for kids ages 2 to 12.
Acetaminophen Overdose: Common Reasons
In providing information to the panel, the FDA found that only a fraction of fatal and non-fatal acetaminophen overdoses in children are reported to the federal agency. However, it listed common reasons for acetaminophen overdoses in children:
Avoiding Acetaminophen Overdose
To avoid these errors -- as well as accidental overdoses by children themselves -- the CHPA offers this advice:
SOURCES: FDA web site.Jeffrey Ventura, spokesman, FDA, email correspondence.News release, Consumer Healthcare Products Association.Consumer Healthcare Products Association briefing information, FDA advisory panel, May 17-18, 2011.FDA briefing information, FDA advisory panel, May 17-18, 2011. ©2011 WebMD, LLC. All Rights Reserved.