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OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions
Date:5/18/2011

WASHINGTON, May 18, 2011 /PRNewswire-USNewswire/ -- The Consumer Healthcare Products Association (CHPA), representing makers of over-the-counter (OTC) single-ingredient acetaminophen medicines for children, applauds the U.S. Food and Drug Administration (FDA) efforts to help parents and caregivers give their children the right amount of medicine. Today, the FDA's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee recommended enhancing the labels of all OTC single-ingredient pediatric acetaminophen products.  If FDA acts on these recommendations, the revised labels would include:

  • Dosing instructions for children between ages 6 months to 2 years of age, based on weight and age; and
  • Dosing instructions by weight (as well as age) on the Drug Facts label for all children's single-ingredient acetaminophen medicines.

"The manufacturers of pediatric acetaminophen products support the FDA advisory committee's recommendations to give parents and caregivers more accurate and detailed dosing information where it is needed – directly on the Drug Facts label," said Scott M. Melville, president & CEO of the Consumer Healthcare Products Association. "The advisory committee unanimously recognized that providing parents and caregivers information on how to dose by weight and how to dose for children 6 months to 2 years of age will help reduce dosing confusion. These recommendations are consistent with our members' longstanding commitment to provide parents and caregivers with devices and information needed to help ensure children receive accurate dosing of these safe and effective medicines."

In a formal vote, the joint committees unanimously voted in support of the addition of weight-based dosing for children ages 2 to 12.  The joint committees unanimously voted that the pharmacokinetic (PK), safety, and efficacy data support the addition of new label directions for children 6 months to 2 years of age.  The committees unanimously voted that the new labeling for children 6 months to 2 years of age include the indication for fever reduction. The committees did not support an indication in labeling for children 6 months to 2 years of age for relief of pain; this indication is currently included for children over 2 years of age.

In addition to including fever reduction as an indication for children 6 months to 2 years of age, CHPA strongly urges FDA to include relief of pain as an indication on the OTC label. Pediatricians recommend acetaminophen as a mainstay for the treatment of pain in children under two years, including pain associated with ear infections, sore throat, teething, and minor traumatic conditions. As experts at the FDA meeting discussed today, physicians can continue to recommend these medicines for pain relief in infants.

In addition to the recommendations discussed at the advisory committee, CHPA member companies recently announced voluntary plans to convert all single-ingredient liquid acetaminophen products for children to a single concentration (160 mg / 5 mL), starting in mid-2011, to help make it easier for parents and caregivers to appropriately use these medicines. Products will continue to be clearly labeled as children's and infants' products and will include flow restrictors that will help make it more difficult for children to ingest large amounts of liquid in the event of an accidental unsupervised ingestion. Syringes will be provided with all infants' products (for children age 3 and under) and children's products (2 years old to under 12 years old) will come with dosing cups. The industry is also voluntarily standardizing all dosing devices with consistent and easily visible measurement markings as well as standardizing the unit of measurement 'mL' on dosing charts and devices.  

As we continue these discussions with FDA, CHPA reminds parents and caregivers to always read and follow the label when giving a child any medicine and to properly store medicines up and away from their children. If parents or caregivers have any questions regarding dosing a child, we strongly recommend that they contact their pediatrician or healthcare professional.

Tips for the safe use and safe keeping of medicines include:

  • Always read and follow the label.
  • Only use the medicine that treats your child's specific symptoms.
  • Store ALL of your family's medicines, including products you use every day high up and out of sight from children.
  • Put medicines away—out of reach and out of sight—EVERY time you use them.
  • Always lock the child safety cap completely every time you use a medicine.
  • Always tell children what medicines are, and do not refer to them as candy.
  • Remind houseguests not to put medicines in purses, bags, coats, or other places small children can get into.
  • Keep the poison control helpline number handy, or program it into your phone: 800.222.1222.

CHPA is the 130-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.

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SOURCE Consumer Healthcare Products Association
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