Statement from the Consumer Healthcare Products Association (CHPA) on FDA’s Options Paper Regarding Acetaminophen

Association supports education, study to further advance the safe use of acetaminophen

Washington, D.C. (May 27, 2009)—Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), issued the following statement in response to the “options paper” released today by the U.S. Food and Drug Administration (FDA) to prompt public discussion on prescription and over-the-counter (OTC) acetaminophen:

“The options paper released today by FDA is part of the agency’s ongoing work regarding safe use of both prescription and OTC acetaminophen. CHPA and the nation’s OTC medicine makers support efforts to help consumers more safely use this important and trusted ingredient. Acetaminophen is the most commonly used medication in the United States and provides safe and effective treatment for pain and fever to nearly 70 million American adults in a given week. Because acetaminophen is so commonly used and prescribed, it is important to ensure that American consumers are aware that acetaminophen misuse or overdose can have serious health risks, including the risk of liver damage. According to FDA, acetaminophen is an important and safe drug when used as directed for the treatment of pain and fever and has stressed the value of its continued availability to consumers.

“CHPA strongly supports additional educational efforts to ensure that consumers understand that acetaminophen can be found in both prescription and OTC products, that they should never take more than the recommended dose or take it for longer than directed, and that misuse or overdose of acetaminophen may cause liver damage. The CHPA Educational Foundation already has consumer-friendly information on to help answer various questions about the safe use of OTC medications, including acetaminophen.  CHPA looks forward to working with the FDA and other interested parties to further build awareness among consumers about how to safely and effectively use acetaminophen. For example, we suggest that labels on prescription medicine bottles clearly list the ingredient acetaminophen, as OTC medicines do, rather than the abbreviation ‘APAP.’

“The recommendations in the FDA report are put forward as possible options for discussion at the upcoming advisory committee in June.  We are assessing these recommendations and look forward to sharing our perspective in more detail at the advisory committee meeting.”

Contact: Mimi Pappas, 202.429.9260

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