CHPA Statement on FDA Advisory Committees Meeting on NSAIDs and Cardiovascular Risks Safety Review
Association says OTC Drug Facts label contains the information that consumers need to use nonprescription NSAIDs appropriately
WASHINGTON--(BUSINESS WIRE)--The Consumer 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):
“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.”
“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 important 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 states:
- 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 a physician.
- 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.