Statement From the Consumer Healthcare Products Association on Today's Joint FDA Advisory Committee Recommendations on Over-the-Counter Medicines Containing Acetaminophen
| Quelle: Consumer Healthcare Products Association
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."
For more information and b-roll, please visit
http://www.firstlinemedia.com/epk/chpa
CHPA is the 128-year-old trade association representing U.S. manufacturers
and distributors of over-the-counter medicines and nutritional supplements.
chpa-info.org | OTCsafety.org