Drugmakers to Standardize Pediatric Liquid Acetaminophen Product Concentration

Move to Drop Infant Formulation Aims to Minimize Dosing Errors

May 16, 2011 03:20 pm News Staff
[Stock image of kids' Tylenol products]

Although cold and flu season is still months away, physicians and parents should be aware that the manufacturers of single-ingredient OTC pediatric liquid acetaminophen products plan to convert all such products to a single concentration.

That means infant products -- such as Infants' Concentrated Tylenol Drops and its generic equivalents -- no longer will be available in an 80 mg/0.8 mL formulation. Instead, all pediatric liquid acetaminophen products will have the 160 mg/5 mL formulation used in Children's Tylenol Suspension and generic versions of that product.

Better Dosing Devices, Consumer Education Key to Avoiding Acetaminophen Overdose

More than 78,000 emergency department visits each year in the United States due to nonabuse-related overdoses of acetaminophen, according to a study(www.ajpmonline.org) recently published in the American Journal of Preventive Medicine.

A related study(www.ajpmonline.org) (abstract) in the same issue of the journal reported results of a survey of six focus groups that found only 41 percent of participants read the ingredients on drug labels, and only 31 percent knew Tylenol contained acetaminophen.

"It's incredibly alarming," said Michael Wolf, Ph.D., M.P.H., an associate professor of medicine at Northwestern University Feinberg School of Medicine in Chicago and senior author of the survey study, in a news release(www.northwestern.edu). "People may unintentionally misuse these medicines to a point where they cause severe liver damage. It's easy to exceed the safe limit if people don't realize how much acetaminophen they are taking."

Meanwhile, in an effort to reduce the risk of accidental overdose in children, the FDA released final guidance(www.fda.gov) for industry May 4 regarding OTC liquid drugs packaged with measuring devices:

  • dosage delivery devices should be included for all orally ingested OTC liquid drug products;
  • delivery devices should be marked with calibrated units of liquid measurement that are the same as the units specified in the product's directions; and
  • liquid measurement markings on delivery devices should be clearly visible and not obscured when the product is added to the device.

The agency also issued the following tips for parents and caregivers giving medication to an infant or child:

  • always read and follow the drug facts label on the medication;
  • know the active ingredient in the medication;
  • use the dosing tool that comes with the product;
  • know the child's weight; and
  • store all medications in a safe place.

"The purpose of this transition is to help minimize the potential for medication errors due to confusion between infants' and children's acetaminophen products having different concentrations," said McNeil Consumer Healthcare, the maker of Tylenol, in a May 4 letter to health care professionals(www.tylenolprofessional.com).

The transition is consistent with a recommendation made in 2009 during a joint meeting of the FDA's Drug Safety and Risk Management, Nonprescription Drugs, and Anesthetic and Life Support Drugs advisory committees.

Infant products will be packaged with new dosing directions and oral syringes that limit the amount of product that can be administered in a single dose, according to a May 4 news release(www.chpa-info.org) from the Consumer Healthcare Products Association, or CHPA.

CHPA said some markers of OTC pediatric acetaminophen products will begin shipping the reformulated infant products by summer.

That won't be the case with McNeil and Infants' Concentrated Tylenol Drops. McNeil recalled(www.fda.gov) all lots of more than 40 formulations of its children's and infants' allergy and pain relief products -- including Tylenol products -- in April 2010 because of manufacturing deficiencies that could affect the products' quality, purity or potency. The company said in its recent letter to health care professionals that Tylenol infant drops are not expected to return to the market before fall.

CHPA said in its news release that consumers should be aware that during the transition, infant products with both the 80 mg/0.8 mL and 160 mg/5 mL formulations could be in stores and medicine cabinets at the same time.

"Consumers should always read and follow the label and pay particular attention to the concentration, especially when a healthcare provider gives dosing instructions," the association said.

McNeil emphasized that health care professionals also should be aware that both the old and new infant acetaminophen products will be on the market at the same time. The transition to the new formulation is expected to continue into next year.

"We ask your support in proactively discussing this change with parents and caregivers and ask that you and your staff always verify what product concentration parents and caregivers are using before providing dosing directions," McNeil said in its letter.

McNeil and CHPA both said consumers could continue to use pediatric acetaminophen products currently on the market as labeled.

Physicians with questions related to pediatric formulations of Tylenol may contact McNeil's health care professional line at (866) 948-6883.