(WASHINGTON, D.C.) — The Consumer Healthcare Products Association (CHPA) today issued the following statement in response to the Food and Drug Administration’s (FDA’s) Drug Safety Communication on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs).
Today’s FDA communication states that the agency is strengthening the existing cardiovascular warning on prescription products to state that non-aspirin NSAIDs can increase the risk of heart attack or stroke in patients. FDA states it intends to request updates to over-the-counter (OTC) non-aspirin NSAID labels in the future. 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 differ from prescription NSAIDs in indication, dose, and duration of use. OTC NSAIDs 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. OTC NSAIDs are used to temporarily reduce fever and to treat minor aches and pains due to headache, minor pain of arthritis, menstrual cramps, muscular pain, and the common cold. OTC non-aspirin NSAIDs include the active ingredients ibuprofen, ketoprofen, and naproxen sodium.
"Millions of consumers rely on OTC NSAIDs to relieve short-term pain and reduce fever, and these medicines have a long history of safety and efficacy when used as directed. The current OTC label addresses potential cardiovascular risks and directs consumers to take the smallest effective dose. 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. We look forward to learning more from FDA and will work with the agency to make appropriate changes to the OTC Drug Facts label to ensure continued safe consumer use.
CHPA encourages consumers relying on these medicines for pain relief to discuss their use with their doctors if they have any questions.
The current OTC Drug Facts label contains 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 or after heart surgery.
- The risk of heart attack or stroke may increase if you use more than directed or for longer than directed."
