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Aspirin Taken with Another NSAID May Triple Risk for Ulcers, Bleeding

Study shows risk of serious GI problems intensified by common OTC pain medications

Oct. 31, 2005 – Senior citizens, who often take a daily aspirin for cardiovascular protection and an occasional ibuprofen or naproxen for pain relief, need to take heed of a study released today that says combining the two significantly increases the risk of gastrointestinal complications including ulcers, perforations and bleeding.

The conclusion that the risk for these problems was two to three times greater for those on both medicines was the results of a large retrospective review of medical records for over 3.2 million individuals. The findings were presented today at the 70th Annual Scientific Meeting of the American College of Gastroenterology.

Researchers from the University of Utah and Pfizer Inc. included 11,957 patients on naproxen (220 mg) and 38,507 patients on ibuprofen (200 mg) in this study that used GE Medical System's Centricity database.

Excluded from the analysis were patients who took steroids, used blood thinners such as warfarin (Coumadinâ), or had other significant health problems.

Patients on ibuprofen and naproxen, known as non-steroidal anti-inflammatory drugs (NSAIDs), were 2.5 to 2.74 times more likely to experience serious GI problems such as ulcers, perforations or bleeding than those who did not take over-the-counter pain medications.

When the researchers looked at the smaller groups of ibuprofen and naproxen users who also took aspirin, there was increased risk of serious problems.

Patients taking both ibuprofen and aspirin had a risk of serious GI problems that was 3.4 times higher than patients taking just ibuprofen.

For the naproxen and aspirin users, their risk was 2 times higher than those on naproxen alone. "Aspirin can significantly increase the risk of problems among patients using other over-the-counter NSAIDs," according to Joseph Biskupiak, Ph.D. of the University of Utah.

The Dangers of Aspirin & NSAIDS

Regular use of NSAIDS is the second major cause for ulcers caused by irritation of the stomach, according to a presentation on the Website of the ACG.

Below are some of the highlights.

●  If you are taking over-the-counter pain medications on a regular basis, you will want to talk with your physician about the potential for ulcers and other GI side effects. NSAID-induced gastrointestinal side effects can be reduced by using alternative therapy. Your doctor may recommend that you change the medication you are using; or add some other medication in conjunction with your pain medication.

●  At one time aspirin was virtually the only non-prescription pain reliever available. It has always had excellent pain relief benefits, but it was also recognized that, when used regularly, it could cause digestive problems for some patients. Some modified versions of aspirin came onto the market in an effort to achieve the benefits of aspirin while "buffering" the prospect for stomach discomfort. Acetaminophen achieves similar benefits of pain relief, with minimal, if any, impact on the stomach lining.

New NSAID medications became available in prescription form that also offered excellent pain relief, but like aspirin, these new prescription medications also had the potential to promote the development of ulcers and bleeding in the GI tract. Since they were being administered under a doctor's prescription, any such effects could be monitored.

NSAIDs became more popular as prescription remedies, and the FDA has approved several for sale to consumers without a prescription. A partial list of NSAIDs that are available over-the-counter and recommended maximum daily doses is below.

●  Some Health Benefits Associated with Aspirin and NSAIDs

The main benefit recognized early on for aspirin was the relief of pain and the reduction in fever. Other important health benefits from aspirin have also come to be recognized. One of the more important of these is the use of aspirin in helping to prevent heart attack and perhaps stoke. The benefit stems from aspirin’s role as a platelet inhibitor. Studies have shown that these benefits can be obtained with a relatively small daily dose of aspirin.

NSAIDS were found to have an additional benefit of reducing inflammation, and so helped alleviate not only the symptom of pain, but also served to reduce the actual cause of the pain, for example, reducing joint inflammation in arthritis.

●  Balancing Pain Relief and Concerns with Side Effects

Adverse side effects can accompany the benefits in a portion of patients taking any medication. No drugs escape the need for this kind of risk-benefit evaluation. It has become necessary to balance the benefits of analgesia, platelet inhibition, and anti-inflammatory effect from NSAIDs and aspirin against potential adverse effects on the stomach and digestive system. For patients who are dependent on regular use of pain relievers, this can mean determining whether there are alternate ways to achieve pain relief, without risking ulcers or GI bleeding which may accompany regular use of aspirin and NSAIDs.

In this regard, aspirin and NSAIDs have been found to cause damage to the lining (or mucosa) of the digestive tract primarily in the stomach and upper intestine. This damage can result in an ulcer or intestinal bleeding. Although this can happen to an individual who is an infrequent user of aspirin or NSAIDs, it is of a much greater concern in frequent users, and those consuming higher dosages of these medications.

●  Personal Medical History is Important

As with any other risk-benefit analysis, the determination of the risk associated with a particular patient's use of NSAIDs requires a careful look at the patient's medical history. Here are some key issues:

Age: Has been identified as a risk factor in several studies. Older patients also often require pain medications more often or in larger doses, further increasing their risk.

Previous Ulcer: A history of an ulcer or an ulcer complication have been identified in several studies as risk factors for complications due to aspirin or NSAIDs use.

Alcohol: Alcohol, taken alone can cause irritation of the GI tract. There have been some indications that patients who consume alcohol at the same time they are taking aspirin or NSAIDs have an increased risk of damage to the intestinal lining, including ulcers and GI bleeding. There have been some reports that chronic heavy alcohol users may be at increased risk of liver toxicity from excessive acetaminophen use. Individuals who consume large amounts of alcohol should not exceed recommended doses of acetaminophen. In 1993, FDA Advisory Committees recommended that all OTC pain relievers contain an alcohol warning--to date, some, but not all OTC pain relief products have complied with that recommendation. Chronic heavy alcohol users should consult their physician for advice on when and how to take pain relievers.

Steroids: Patients taking NSAIDs who also are taking a prescription corticosteroid, medications like prednisone (in doses over 10 mg), have been found to have a seven fold increased risk of having GI bleeding.

Anti-coagulants: Similarly, patients who are taking NSAIDs at the same time they are taking oral prescription anti-coagulants (for example, medications like coumadin) have been found to have a 12-fold increased risk of bleeding.

●  Magnitude of NSAID Use

Adverse effects associated with NSAIDs become more likely as the cumulative amount of NSAID increases, relating both to the size of each dose you take, as well as how frequently–how many times a day, how many days a week–you consume NSAIDs.

The most important ground rule, however, is to follow the instructions on your medication. No medication–whether a prescription or over-the-counter drug–should be taken more frequently than is directed in the labeling.

Most NSAID ulcers heal easily if the NSAIDs are stopped. If the medication cannot be stopped, the dose may often be reduced. Even if your physician determines that continued administration of NSAIDS is needed, healing can still occur.

●  Asymptomatic Patients—Patients Can Have an Ulcer or GI Bleeding without any Obvious Symptoms

An individual can develop damage to the intestinal lining without being aware of it—significant GI bleeding occurs frequently without any symptoms being present.

Of particular concern are patients with arthritic conditions. More than 14 million such patients consume NSAIDs regularly. Up to 60% will have gastrointestinal side effects related to these drugs and more than 10% will cease recommended medications because of troublesome gastrointestinal symptoms.

●  Medications That May Be Taken to Inhibit or Reverse the NSAIDs-Induced Injury to the Intestinal Lining and GI Bleeding

Conventional treatments for ulcers (classes of prescription ulcer drugs called H2 blockers and proton pump inhibitors), have been found to have a beneficial effect in treating NSAID-induced ulcers and in preventing GI bleeding. These treatments often will be effective, particularly if NSAID use is stopped or reduced, although healing can occur in many cases where a patient receives these anti-ulcer medications, even when NSAID use continues.

Another medication, misoprostol, has been used effectively to prevent gastric and duodenal ulcers and has been shown to reduce the risk of bleeding in those that must continue using NSAIDs. As with all instances where patients are taking more than one prescription or over-the-counter medication, patients and their physicians need to evaluate any side effects, potential drug interactions, or other factors, for example limitations on use during pregnancy.

●  What can you do if you are concerned about avoiding GI bleeding?

If you are taking over-the-counter NSAIDs on a regular basis, you will want to talk with your physician about the potential for ulcers and other GI side effects. Most patients contact their family doctor, or primary care physician, when they experience GI problems. Many of these disorders, including Helicobacter pylori infection, can be treated readily by your primary care doctor.

In the case of recurring or more serious problems, you may need to see a gastroenterologist, a physician who specializes in disorders and conditions of the gastrointestinal tract.

●  Things to Remember about NSAIDs

NSAIDs and aspirin have some very positive health benefits. Like all medications, care must be taken with their use. For example, they should not be taken with alcohol, as the combination can increase the risk of GI bleeding. Patients who need to use NSAIDs regularly should consult regularly with their physician to be alert for any potential GI effects. Since problems may arise with few, if any, symptoms, ongoing monitoring with your physician is important. If problems do arise, and are recognized early, there are a variety of ways to minimize or reverse any adverse effects, either by using alternatives to NSAIDs, or through your physician prescribing medications that can reduce any adverse effects.

This entire report can be found at http://www.acg.gi.org/patients/women/asprin.asp.

About the American College of Gastroenterology
The ACG was formed in 1932 to advance the scientific study and medical treatment of disorders of the gastrointestinal (GI) tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the needs of clinical gastroenterology practitioners. Consumers can get more information on GI diseases through the following ACG-sponsored programs:

●  1-800-978-7666 (free brochures on common GI disorders, including ulcer, colon cancer, gallstones, and liver disease)

●  1-866-IBS-RELIEF and www.ibsrelief.org (free educational materials)

●  1-800-HRT-BURN (free brochure and video on heartburn and GERD)

●  www.acg.gi.org (ACG's Web site)

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