Naproxen was found to neither increase nor decrease cardiac risk in a huge meta-analysis published online by the Journal of the American Medical Association September 12, 2006. The review of 23 studies on pain relievers involving some 1.6 million people were not gold-standard clinical trials, but their sheer scope lends it weight.
The research looked at all non-steroidal anti-inflammatory drug (NSAIDs) studies across the board and all available evidence for each. It found that an older NSAID named diclofenac, which has been on the market for decades and is one of the most widely prescribed anti-inflammatories in the world—especially in Europe—was found to increase the risk of cardiovascular events by 40%.
Even the newer NSAID COX-2 drugs, like Vioxx, Bextra and Celebrex, were linked to heart-related risk, for which Vioxx and Bextra were removed from the market in 2004 and 2005, respectively.
Naproxen, which has been around for years, did not raise heart attack or stroke risk.
The drawback is that the drug can and does irritate the stomach. Some doctors recommend certain patients may also need to take one of the newer acid reflux drugs.
Like all painkilling drugs, side effects from naproxen can be very serious, even fatal, from misuse or chronic overuse.
This medication is a NSAID which relieves pain and swelling (inflammation). It works by inhibiting both the COX-1 and COX-2 enzymes that make prostaglandins. Decreasing prostaglandins helps to reduce pain, swelling, and fever.
Naproxen and naproxen-sodium are marketed generically and under various trade names including: Aleve, Anaprox, Miranax, Naprogesic, Naprosyn, EC-Naprosyn, Naprelan, Proxen, and Synflex.
It remains a prescription-only drug in much of the world. The U.S. Food and Drug Administration (FDA) approved the use of naproxen sodium as an over-the-counter (OTC) drug in 1994, where OTC preparations are sold under the trade name Aleve.
As a non-prescription drug, Aleve is used for adults and with children over age 12 for minor to moderate arthritis, headaches, muscle aches, backaches, tendonitis, bursitis, dental pain, menstrual cramps, arthritis, or gout. This medication is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu.
As a prescription drug, it is commonly used for the reduction of moderate to severe pain, fever, inflammation and stiffness caused by conditions such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, menstrual cramps, tendinitis, bursitis, and the treatment of primary dysmenorrhea.
It was originally marketed as the prescription drug Naprosyn in 1976 and naproxen sodium was first marketed under the trade name Anaprox in 1980.
Stop taking naproxen and seek medical attention or call your doctor at once if you have any of these serious side effects:
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
This medication should not be used if you have certain medical conditions. Before using it, consult your doctor or pharmacist if you have:
Before taking this medication, tell your doctor if you are taking any of the following drugs (If you are using any of these you may not be able to take naproxen or you may need dosage adjustments or special tests during treatment):
There may be other drugs not listed that can affect naproxen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication, whether synthetic or natural, without telling your doctor.
Because many medicines available over the counter contain aspirin or other drug classes similar to naproxen (such as ibuprofen or ketoprofen), if you take certain products together you may accidentally take too much and be at risk of overdose.
Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or ketoprofen.
In addition, be careful to realize that you may be taking another medication that contains the drug without your knowledge. You should be aware of its content in other over-the-counter or prescription products, to avoid taking more than the recommended amount per day. It’s always best to tell your medical practitioner exactly what medications you are taking whether prescription or non prescription.
Like other NSAIDs, this medication can inhibit the excretion of sodium and lithium. Extreme care must be taken by those who use this drug along with lithium supplements. It is also not recommended for use with the NSAID aspirin of the salicylate family (drugs may reduce each other's effects) or with anticoagulants (may increase risk of bleeding).
According to the March, 2008 publication, Rheumatology News, the ten most often prescribed arthritis drugs did not include the NSAID naproxen. Based on an analysis of 7,945,910 prescriptions written by rheumatologists from January to March 2008, the top 10 list included:
The drug of choice for mild to moderate arthritis pain is acetaminophen (Tylenol), because when used as directed it has very few side effects and is relatively inexpensive. It is available both non-prescription and prescription. However, it does not reduce inflammation from arthritis. It may cause liver problems in people who consume alcohol in large amounts.
The second drugs of choice for somewhat greater pain (moderate to moderate-severe) are NSAIDs, including aspirin, ibuprofen and naproxen as they treat pain as well as inflammation, and are relatively inexpensive. They are available both non-prescription and prescription. However, NSAIDs have gastrointestinal side effects and may interfere with other medications or cause serious side effects.• Talk to your doctor before taking any NSAIDs.
The third drug of choice for moderate to severe arthritis pain is the prescription NSAID COX-2 Inhibitor, celecoxib (Celebrex) that does not cause stomach irritation. COX-2 drugs are often more expensive than other NSAIDs. COX-2 drugs have been linked to heart problems that caused two other brands, Vioxx and Bextra, to be removed from the market in recent years.
Celebrex continues to be sold, but the Food and Drug Administration (FDA) has issued a physician’s warning concerning possible heart-related side effects.
On August 23, 2006, the online journal Birth Defects Research published a study Developmental and Reproductive Toxicology- Part B on the risk of congenital anomalies in pregnant users of non-steroidal anti-inflammatory drugs.
The results indicated that pregnant women who take NSAIDs including naproxen in the first trimester run an increased risk of having a child with congenital birth defects, specifically cardiac septal defects.
An observational study published in the February 26 2007 issue of the Archives of Internal Medicine reports "use of common pain relievers (is) associated with increased risk of elevated blood pressure in men." The study followed a total of 16,031 male health professionals (average age 64.6 years) who did not have a history of high blood pressure, but who used three types of pain relievers: 1) acetaminophen, 2) the NSAIDS ibuprofen and naproxen, and 3) aspirin.
The study was led by John P. Forman, M.Sc., M.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston. It is generally believed that all NSAIDs may have the potential to positively or negatively effect hypertension.
On December 23, 2004 the Food and Drug Administration (FDA) issued a public alert for non-prescription Aleve and prescription preparations about the possible dangers of suffering heart attack or stroke as a result of using this drug. The alert stated: “Based on emerging information, the risk of cardiovascular and cerebrovascular events may increase among patients taking naproxen. FDA recommends patients not exceed the recommended dose.”
The cardiovascular safety alert on naproxen is the first of its kind since this drug first hit the US market in 1976. Common warning statements for the drug have long included side effects such as gastrointestinal complications, photosensitivity, headache, and edema. Its warning contraindications caution patients with a history of heart disease, liver and kidney problems, coagulation (blood clotting) conditions, high blood pressure, and people with allergic reactions to similar medications.
The FDA alert on this drug in the above paragraph was precipitated by the National Institutes of Health (NIH) prematurely terminating a randomized clinical trial of naproxen and celecoxib for prevention of Alzheimer’s disease after naproxen became linked to increased cardiovascular risk.
The NIH began a three year study called ADAPT in 2001 but the study was halted in late 2004 after preliminary trial results indicated that patients taking naproxen were twice as likely to suffer heart attack or stroke as patients in taking a placebo pill.
However, in the following year, a meta-analyses of 64 online research journals published November 28, 2005 in the BioMed Central (BMJ) Journal concluded that long-term use of naproxen and a similar NSAID, ibuprofen, did not appear to increase a person’s risk of having a heart attack or stroke.
Close to 5,000 heart attack patients and 20,000 people who had not had heart attacks were included in the study. Researchers reported no increase in risk among people who took either ibuprofen or naproxen for a year or longer in moderate doses. The two drugs are among the best-selling NSAIDs.
This stands in contrast to other NSAIDs, such as rofecoxib (Vioxx), celecoxib (Celebrex), valdecoxib (Bextra) and diclofenac Voltaren), which did show significantly increased risk at some or all dosages.
Vioxx was pulled from the market in 2004 amid concerns about an increase in heart attack and stroke risk among users. The pain reliever Bextra, chemically similar to Vioxx, was withdrawn from the market for the same reason in April, 2005.
The late-2005 findings may help to allay the fears of regular naproxen or ibuprofen users, but in February 2007, the American Heart Association (AHA) released a scientific statement advising that, when possible, physicians should avoid using NSAIDs in patients at high risk for heart disease.
When pain relief is necessary, the AHA advises that doctors should preferentially use acetaminophen or aspirin. Spokesman David Herrington, MD, MHS, a Wake Forest University cardiology professor who co-authored the advisory, commented, “We said that people should try to use the simplest and safest medications first in the recommended dosages for the shortest possible period of time. For most people, that means aspirin or acetaminophen (Tylenol), which have the longest and most well-established safety records.”
The AHA recommends naproxen, ibuprofen and other NSAIDs be used only under a doctor’s supervision for chronic pain for people who can’t take aspirin or acetaminophen or who don’t get adequate pain relief from them.
"Every treatment decision is a balance of safety and efficacy, and this is certainly no different," Herrington says. "People shouldn't suffer unnecessarily, but it is important that people who take these drugs long term get guidance from a physician."
A study published in the Arthritis Research & Therapy Journal, January 31, 2007 showed that 11.4% of juvenile idiopathic arthritis (JIA) patients between the ages of 4 and 5 developed pseudoporphyria (blisters, skin eruptions, sores ) as a side effect of naproxen treatments.
Pseudoporphyria (PP) occurs primarily as facial lesions, mostly on the cheeks and nose and can cause permanent scarring. Naproxen is one of the most commonly prescribed drugs in the therapy of JIA.
The mean duration of treatment before onset of PP was 18 months and in particular affected patients diagnosed with early-onset pauciarticular (EOP) JIA who had significant inflammation and appeared prone to the drug’s side effect.
The study concluded that the potential risks associated with this medication should be carefully considered, especially in fair-skinned children, who are young (under 5) and diagnosed with EOPA-JIA.
If you could achieve the arthritis or other pain relief you need safely, without total reliance on drugs, wouldn’t it be worth a try?
Naproxen, like all painkilling drugs, has potential serious side effects from over use. Do you have pain that requires non-prescription or prescription medication as many as five days a week, month after month?
If so, you may wonder about the potential damage this drug has on your stomach, kidneys or other organs.
It’s possible and very likely you can free yourself completely (or cut back substantially) from pain relief drugs by switching to safe, natural alternatives.
For centuries, nature contained the answers for pain relief. There are many botanical and herbal substances that have been clinically proven effective and safe. They’re readily accepted by your body because they’re natural. The body assimilates plant, botanical and herbal substances as nutrients which also helps with overall health.
Below are three recommended and trusted natural pain relief products that may replace or lessen reliance on naproxen. They have been helpful for thousands of people in attaining relief from back pain and joint pain relief from injury, surgery or arthritis (click the bold blue links on the left to obtain prices and further information):
For information thumbnails on each, click on the following link: The Pain Trio
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Disclaimer: Health statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
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