|[February 10, 2014]
CHPA Statement on FDA Advisory Committees Meeting on NSAIDs and Cardiovascular Risks Safety Review
WASHINGTON --(Business Wire)--
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
OTC NSAIDs are not intended to be used for more than 10 days for pain
(and 3 days for fever) unless directed by a physician.
If the pain/fever condition persists beyond the labeled duration, the
consumer is directed to stop use of the product and seek the advice of
Ask a doctor before use if you have high blood pressure, heart
disease, liver cirrhosis, or kidney disease.
Consumers should not take more than directed and that the smallest
effective dose should be used.
Consumers are also directed to talk to a healthcare professional
before taking multiple medications at the same time.
Consumers should not use if you have ever had an allergic reaction to
any other pain reliever/fever reducer or right before heart surgery."
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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