Pharmaceutical

Potential dosing errors with new infant acetaminophen

A new concentration of liquid acetaminophen for infants is now available over-the-counter, but the Food and Drug Administration (FDA) warns that this new concentration may lead to dosing errors, which could be potentially dangerous to infants.

The new liquid acetaminophen, marketed for infants, comes in 160mg/5 mL concentration, and calls for a different dosing than the 80 mg/0.8 mL or 80 mg/mL previously sold in retail stores. Both concentrations are now available.

Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache. It is sold under the brand names Tylenol, Little Fevers, Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants’ Syrup Fever Reducer Pain Reliever, and other store brands such as Rite Aid, CVS, and Walgreens. The new concentration is packaged with either an oral syringe or a dropper.

The new concentration comes just months after the American Academy of Pediatrics and drug manufacturers petitioned the FDA to update dosing instructions for acetaminophen in an effort to prevent accidental overdoses. Three percent of the 270,000 reported overdoses of acetaminophen in 2010 involved dosing errors involving children’s acetaminophen.

This change in dosing will affect the amount of liquid given to an infant, and should be noted by people who are accustomed to using the smaller concentration in order to avoid accidental overdosing or under-dosing. A too small dose may be ineffective, whereas a too large dose could cause serious side effects and, possibly, death.

Consumers should be sure to read the label on the packages of liquid acetaminophen for proper dosing, and use the dropper or oral syringe included in the package for measuring the correct amount of liquid. Any side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA
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