Study Shows that Popular Over-the-Counter Pain Medications Can Cause Serious Stomach Problems

Study Shows that Popular Over-the-Counter Pain Medications Can Cause Serious Stomach Problems

Oct 31, 2005 5:00 PM

Data Presented at American College of Gastroenterology 2005 Annual Scientific Meeting

HONOLULU, November 2 Over-the-counter (OTC) doses of non-steroidal anti-inflammatory drugs (NSAIDs) ibuprofen and naproxen can increase the risk of the gastrointestinal (GI) complications, perforations or holes in the stomach lining, ulcers and GI bleeds -- together referred to as PUBs -- according to a substantial review of a national electronic database of 3.2 million patient health records. An analysis of the data shows that patients taking low-dose aspirin at the same time as ibuprofen or naproxen have an even greater likelihood for GI events than those who do not take aspirin. Joseph Biskupiak, Ph.D., the studys lead author and research associate professor of pharmacotherapy at the University of Utah College of Pharmacy, presented these data at the annual scientific meeting of the American College of Gastroenterology (ACG).

The analysis evaluated the probability for GI complications among more than 50,000 people by comparing the incidence of PUBs during the three months after taking ibuprofen or naproxen, even one time, versus the six and 12 months before taking either of these non-selective NSAIDs (ns-NSAIDs). The 15-month time frame was studied to allow for observation of the potential impact of ns-NSAID use on PUBs. During the three months after taking ibuprofen, patients were 2.5 times more likely to develop PUBs than they were during the six months before taking it. Patients who took naproxen were 2.74 times more likely to develop PUBs than they were during the six months before taking it.

During the three months after taking either ibuprofen or naproxen, the probability of developing PUBs rose significantly when patients also took aspirin: Patients taking both ibuprofen and aspirin were 3.36 times more likely to develop PUBs versus taking ibuprofen alone. Patients taking both naproxen and aspirin were 2.07 times more likely to develop PUBs versus taking naproxen alone.

Almost 60 million adults in the United States take OTC pain relievers every day or several days per week. The U.S. Food and Drug Administration (FDA) requested that the manufacturers of OTC NSAIDs advise people to take the drugs as directed in the label. Many labels specify that the drugs should not be taken for more than 10 days without talking to a healthcare provider.

It is very important that patients discuss their use of over-the-counter pain medications with their physicians, especially if used over a prolonged period of time, noted Dr. Biskupiak. There are significant GI risks associated with use of OTC ibuprofen or naproxen that people may not be aware of.

It was estimated that stomach complications from using OTC and prescription ns-NSAIDs have sent more than 100,000 people to the hospital each year. And over 16,000 people have died. At a conservatively estimated cost of $15,000 to $20,000 per hospitalization, the annual costs exceed $2 billion.

The FDA has advised that all NSAIDs, including OTC and prescription drugs, should have stronger warnings to alert people to the potential risks of heart, stomach and skin problems.

About The Study The new retrospective review of a U.S.-based electronic database of 3.2 million outpatient medical records was designed to assess the risk for PUBs using OTC naproxen 220 mg or ibuprofen 200 mg. A set of 11,957 subjects on naproxen and 38,507 subjects on ibuprofen met these criteria. Patients were excluded if they had taken oral steroids or coumadin, or if they had any of the following conditions that might have influenced the development of PUBs: infectious diseases, GI cancers, enteritis, colitis, or diverticula of the intestines. The first time a patient took either ibuprofen or naproxen was considered the index date from which to compare the incidence of PUBs before and after. Using these data, researchers were able to determine whether the odds for developing a PUB were increased by ibuprofen or naproxen use.

Support for this study was provided by Pfizer Inc.

The University of Utah is internationally regarded for its research and clinical expertise in the health sciences. Through its four major health sciences collegesthe University of Utah School of Medicine; College of Pharmacy; College of Nursing; and College of Healththe University of Utah is the premier primary-care provider in the Intermountain West and also trains most of the state of Utahs physicians, pharmacists, nurses, therapists, and other health-care professionals.

For Information Contact:

Phil Sahm, Office of Public Affairs, 581-2517

Joseph Biskupiak, Ph.D., 801-450-1390

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