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Drug Industry Plans Transition to One Concentration for Pediatric Liquid Acetaminophen Products

June 01, 2011

On May 4, 2011, the Consumer Healthcare Products Association (CHPA) announced that over-the-counter (OTC) drug manufacturers will voluntarily discontinue production of infant-strength liquid acetaminophen products (e.g., Infants’ Concentrated Tylenol® Drops) by mid-2011.1 The manufacturers plan to establish one standard concentration for single-ingredient liquid acetaminophen (160 mg per 5 mL) for all children under 12 years of age to simplify product selection, reduce dosing errors and improve patient safety.

These steps are part of an industry-wide effort to reduce the potential for medication errors due to the different concentrations that are currently available in liquid acetaminophen products for infants and children. Currently, the children’s concentration of liquid acetaminophen medication is 160 mg per 5 mL (equal to one teaspoonful), but more concentrated forms of single-ingredient acetaminophen drops for infants (e.g., 80 mg per 0.8 mL) have also been available in the OTC marketplace for years. While the concentrated-drop formulation is intended to deliver acetaminophen in a suitable volume for infants, it raises the potential for medication errors for parents and caregivers (e.g., over an 8-year period, one manufacturer reported over 1,000 consumer inquiries about pediatric dosing of liquid acetaminophen products).

The transition announced by CHPA was prompted in part by recent advisory panel meetings of the U.S. Food and Drug Administration (FDA), which has considered a range of options for addressing the persistent public health issue of acetaminophen-related liver injury. The OTC industry’s plans are aligned with new guidance from the U.S. Food and Drug Administration (FDA) on dosing delivery devices for liquid OTC medications,2 which presents recommendations for improved dosing devices (e.g., syringes, calibrated cups, spoons) in product packaging to minimize accidental errors with non-prescription drugs.

The move toward a single concentration of pediatric liquid acetaminophen is significant for the dental profession because acetaminophen is commonly used to manage various forms of dental pain in adults and young children. Parents and caregivers also routinely give acetaminophen to infants and young children to relieve fever and pain, often of non-dental origin. When used as directed, acetaminophen has a long history of safety and effectiveness as an effective analgesic and antipyretic (fever reducer). Yet while acetaminophen is available in many OTC products and is widely accepted for the treatment of mild to moderate pain, it also carries potential risks for liver injury when used excessively or when taken in combination with other acetaminophen-containing products (prescription or OTC).

The transition to one standard acetaminophen dose in pediatric liquid products is expected to begin in summer 2011, and will continue into 2012 as single-ingredient, concentrated acetaminophen drops are discontinued from the marketplace. As this process occurs, multiple concentrations of liquid acetaminophen products may continue to be available in retail stores. During this transition phase, parents and caregivers should be advised to pay close attention to acetaminophen dosage and proper dose intervals when giving liquid acetaminophen to infants and young children (particularly if using the concentrated acetaminophen drops that are being discontinued). When the OTC industry completes the transition process, liquid acetaminophen products for infants will be sold with flow restrictors and clearly marked syringes to improve dosing accuracy.

Infants, young children and parents/caregivers should be instructed to use acetaminophen and other oral analgesics as directed. They should also be advised that many OTC and prescription medications contain acetaminophen, and the use of multiple acetaminophen-containing medications at the same time can increase an individual’s risk for acute liver injury. For additional information, dentists are encouraged to consult the ADA Council on Scientific Affairs’ Science Brief on Acetaminophen and Liver Injury and the FDA’s Consumer Health Information on the safe use of acetaminophen.

Footnotes

1Consumer Healthcare Products Association. OTC Industry Announces Voluntary Transition to One Concentration of Single-Ingredient Pediatric Liquid Acetaminophen Medicines. May 4, 2011. Accessed May 19, 2011.

2United States Food and Drug Administration. FDA issues final guidance for liquid OTC drug products with dispensing devices. May 4, 2011. Accessed May 19, 2011.

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Science in the News is a service by the American Dental Association (ADA) to its members to present current information about science topics in the news. The ADA is a professional association of dentists committed to the public's oral health, ethics, science and professional advancement; leading a unified profession through initiatives in advocacy, education, research and the development of standards. As a science-based organization, the ADA's evaluation of the scientific evidence may change as more information becomes available. Your thoughts would be greatly appreciated.