Non-steroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over the counter. They are used to relieve fever and pain, such as those associated with headaches, colds, flu and arthritis. Examples of prescription NSAIDs include ibuprofen, naproxen, diclofenac and celecoxib. Ibuprofen and naproxen are also available over the counter in lower concentrations.
What are non-steroidal anti-inflammatory drugs (NSAIDs)?
NSAIDs are a group of drugs used to temporarily relieve pain and inflammation. They work by blocking the production of prostaglandins or chemicals that may be associated with pain and inflammation.
What conditions do NSAIDs treat?
Prescription NSAIDs are important to help manage many debilitating conditions such as osteoarthritis and rheumatoid arthritis. Some prescription NSAIDs are also used to treat pain. Over-the-counter versions of some NSAIDs are used to treat pain associated with dental problems, tendonitis, strains, sprains and other injuries. NSAIDs are also commonly used to treat fever and to reduce the pain associated with menstrual cramps.
What are non-selective NSAIDs and COX-2 selective NSAIDs?
Non-selective NSAIDs work by inhibiting two enzymes involved in inflammation: cyclooxygenase-1 and cyclooxygenase-2 (COX-1 and COX-2).
There are several non-selective NSAIDs on the market, including diclofenac, ibuprofen, ketoprofen, meloxicam, naproxen and oxaprozin. Ibuprofen and naproxen are available in prescription and over-the-counter (OTC) versions. The doses in the OTC NSAIDs are lower than the doses in the prescription versions and should only be used for 10 days without consulting a doctor. So, if you are taking OTC ibuprofen (Advil and Motrin) or naproxen (Aleve), the doses are about half of the doses of the prescription versions.
Selective COX-2 inhibitors are a new type of drug that blocks the COX-2 enzyme more than the COX-1 enzyme. The only selective COX-2 inhibitor currently on the market in the United States is the prescription drug Celebrex (celecoxib), which is marketed by Pfizer. It was thought that COX-2 inhibitors might be less likely to cause stomach problems associated with older NSAIDs, but all NSAIDs carry a risk of stomach problems.
What are the risks of taking NSAIDs?
As with all medications, there is a risk of allergic reaction to NSAIDs. Symptoms may include hives, facial swelling, wheezing and a rash.
There is a risk of gastrointestinal bleeding (bleeding in the stomach or elsewhere in the digestive tract) associated with all NSAIDs. The risk of bleeding is low for people who use NSAIDs intermittently. The risk of stomach problems increases for people who take them daily or regularly, especially for people over 65, people with a history of stomach ulcers, and people who take blood thinners or corticosteroids (prednisone). Drinking alcohol can also increase the risk of stomach problems.
In addition, the use of all NSAIDs, except aspirin, increases the risk of heart attack or stroke. These serious side effects can occur as early as the first few weeks of NSAID use, and the risk may increase the longer people take NSAIDs without aspirin.
All NSAIDs also carry the risk of potential skin reactions. Patients should be alert to symptoms such as skin redness, rash, or blisters.
Aspirin is a non-selective NSAID and has been shown in clinical trials to reduce the risk of certain cardiovascular events in patients who have cardiovascular disease or who have had a heart attack or ischemic stroke. Aspirin is sold in generic forms and under brand names such as Bayer and St. Joseph’s.
Who is most at risk for cardiovascular adverse events associated with NSAIDs?
Who is most at risk for cardiovascular adverse events associated with NSAIDs? People with cardiovascular disease, especially those who have recently had a heart attack, heart bypass surgery or stroke, are at the greatest risk of adverse events. Studies show that people who have had a heart attack are at increased risk of having another heart attack or dying from heart attack-related causes if they are treated with NSAIDs, other than aspirin.
Which selective Cox-2 inhibitors have been withdrawn from the market?
Merck voluntarily withdrew Vioxx (rofecoxib) in 2004 after discovering the results of a study that showed patients taking Vioxx had a higher risk of heart attack than patients taking a placebo. The FDA asked Pfizer to remove Bextra (valdecoxib) from the market in 2005 because the overall risk/benefit profile was unfavorable. The request was based on many factors. Along with other risks associated with NSAIDs, there were a higher than expected number of serious and potentially fatal skin reactions, including death.
An increased risk of cardiovascular adverse events has been demonstrated for all COX-2 inhibitors, including Celebrex, which is still on the market in the United States. Based on the available data, the FDA determined that the benefits of Celebrex outweigh the potential risks in properly selected and informed patients. The FDA has asked Pfizer to include a boxed warning on the Celebrex label and has asked the manufacturers of all prescription NSAIDs to revise their labeling with a boxed warning as well. The boxed warning highlights the potential for increased risk of cardiovascular events as well as serious and potentially fatal gastrointestinal bleeding. Importantly, the FDA also determined that the risk of cardiovascular events was also very likely for non-selective NSAIDs, and all manufacturers of these drugs were asked to add important warnings to their labels.
What can consumers do to reduce their risk with NSAIDs?
Talk to your doctor about your complete medical history, including a history of cardiovascular disease or stomach ulcers. This will help you and your doctor weigh the risks and benefits. You can also ask your doctor what you can do to reduce the risk of stomach irritation, such as taking medication with a meal. Also ask what steps you can take to reduce the risk of cardiovascular disease and report side effects of medications to your doctor. Whether you take a prescription NSAID or an over-the-counter NSAID, following instructions is important. The available scientific evidence does not suggest an increased risk of serious cardiovascular events for short-term, low-dose use of OTC NSAIDs, but it is unclear whether this is because there is no risk or because there is a lot of difficulty in trying to study OTC NSAID use. Be aware that the OTC labeling states that if you take an NSAID for more than 10 days, you should consult your doctor. The lowest effective dose should be used for the shortest time.
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