Statement From the Consumer Healthcare Products Association on Today's Joint FDA Advisory Committee Recommendations on Over-the-Counter Medicines Containing Acetaminophen

WASHINGTON, DC--(Marketwire - June 30, 2009) - Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), regarding the recommendations issued today by the U.S. Food and Drug Administration's Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee. The joint committee addressed the use of over-the-counter (OTC) and prescription (Rx) drugs containing acetaminophen.

"CHPA strongly believes that patients and physicians should continue to have access to the current range of over-the-counter (OTC) acetaminophen-containing products, and we are pleased the committee did not recommend eliminating these important nonprescription products. While we are pleased with the committee's recommendation to allow continued access to OTC combination medicines containing acetaminophen because we know they provide real benefits to consumers, we are disappointed in their divided vote to lower the maximum daily dose and the single dose of 1000 mg acetaminophen. There was a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms.

"There is universal agreement on the safety of acetaminophen when used as directed on the label. We know that the overwhelming majority of adults use this product safely and that the majority of serious adverse events related to unintentional acetaminophen overdose are associated with prescription medicines containing acetaminophen. In addition to the label, the most effective and most appropriate intervention to address overdose is education. We support educational efforts to encourage appropriate use of acetaminophen and have already begun developing a comprehensive research-based education program that includes a consortium of pharmacists, physicians, retailers, FDA, and other healthcare professionals.

"We strongly urge FDA to add dosing instructions on pediatric products intended for children (6 months to under 2 years of age). All of our companies provide dosing instruments with their products. We support the current range of concentrations to easily and safely dose young children.

"We remain committed to continuing our efforts to promote the safe use of acetaminophen and look forward to working with FDA as they review the committee's recommendations."

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CHPA is the 128-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.

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