The National Association of Chain Drug Stores gave its take on the safe use of pediatric acetaminophen products to the Food and Drug Administration.


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NACDS speaks up on safe use of pediatric acetaminophen

May 18th, 2011

ALEXANDRIA, Va. – The National Association of Chain Drug Stores gave its take on the safe use of pediatric acetaminophen products to the Food and Drug Administration.

NACDS said late Tuesday that Kevin Nicholson, vice president, pharmacy advisor, for government affairs and public policy at the association, delivered testimony on the issue before a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.

"As FDA has recognized in the past, acetaminophen is an extremely safe medication when used at recommended doses. In addition, it is one of the most commonly used medications in the United States," Nicholson stated at the meeting. "With this in mind, it is important to ensure that any new policies or regulations affecting availability of acetaminophen products are workable considering the great consumer need for, and widespread use of, these products."

His comments come a couple of weeks after the Consumer Healthcare Products Association (CHPA) announced that makers of over-the-counter, single-ingredient liquid acetaminophen medicine for children are voluntarily transitioning those products to one concentration. With the move, the current children's strength of liquid acetaminophen (160 mg/5 ml) will become the only liquid concentration available for all children under age 12, and the current concentrated infant drops will no longer be sold.

Nicholson expressed NACDS' support of the change in his testimony to the FDA committees. "We are pleased that the makers of single-ingredient pediatric acetaminophen products have announced that they are converting all pediatric liquid acetaminophen formulations to one concentration," he commented. "This, as well as other improvements and initiatives they have announced, will help patients and caregivers accurately dose pediatric acetaminophen products and help prevent medication errors."

The association also expressed its support for weight-based dosing instructions for all children's single-ingredient liquid acetaminophen medicines. "We believe that it will allow for more accurate dosing and help to reduce adverse incidents," stated Nicholson.

NACDS noted that it has been engaged in review of pediatric liquid acetaminophen formulations. In 2009, the association testified before an FDA advisory group detailing its recommendation to include dosing instructions for children under age 2 on labels of OTC single-ingredient acetaminophen products for children.

In addition, NACDS said it's a member of the Acetaminophen Awareness Coalition, led by CHPA and the American Pharmacists Association (APhA), to address acetaminophen-related issues and educational needs.

The coalition soon plans to launch a campaign to educate consumers about the need to follow directions on labels and how to properly use OTC medicines with acetaminophen, NACDS added. Nicholson said in his testimony that one focus of the campaign will be to educate consumers about the importance of knowing if a particular OTC medication contains acetaminophen and not taking two medicines with acetaminophen at the same time.

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