Healthcare Products Association (CHPA) issued the following
statement in response to the Food and Drug Administration's (FDA)
Arthritis and Drug Safety and Risk Management advisory committees
hearing examining cardiovascular risk data for non-aspirin,
non-steroidal anti-inflammatory drugs (NSAIDs):
"Millions of consumers rely on over-the-counter (OTC) NSAIDs to relieve
short-term pain and reduce fever. Each OTC NSAID has been extensively
reviewed prior to and post marketing by FDA and previous FDA Advisory
Committees. These reviews have confirmed that OTC NSAIDs are safe and
effective when used as directed.
"NSAIDs have a long history of safety and efficacy when used as directed
and current OTC labeling contains the information consumers need to
determine if the medicine is right for them to use, how to take the
product, and when to see a doctor if needed.
"It is imporant to distinguish the use and safety of OTC NSAIDs from
that of long-term and/or high-dose prescription NSAID use. OTC NSAIDs,
including ibuprofen and naproxen sodium, differ from prescription NSAIDs
in indication, dose, and duration of use. OTC NSAIDs have a wider margin
of safety because they are for short-term use at lower doses for acute
pain/fever conditions and are not intended to be used on a chronic basis
unless directed by a physician.
"The OTC Drug Facts label contains the information that consumers need
to determine if the medicine is right for them to use, how to take the
product, and when to see a doctor if needed. The labeling for OTC NSAIDs
The Consumer Healthcare Products Association (CHPA) is the
133-year-old trade association representing the leading manufacturers
and marketers of over-the-counter (OTC) medicines and dietary
supplements. Every dollar spent by consumers on OTC medicines saves the
U.S. healthcare system $6-$7, contributing a total of $102 billion in
savings each year. CHPA is committed to promoting the increasingly vital
role of over-the-counter medicines and dietary supplements in America's
healthcare system through science, education, and advocacy.
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