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Newer Pain Relievers No Safer for Stomach
Jan. 25, 2005 - It's long been thought that the blood thinner Coumadin, which is used to help prevent heart attacks or strokes, doesn't mix well with older anti-inflammatory drugs like ibuprofen and naproxen because of a risk of stomach bleeding.
So if a patient is on Coumadin and has arthritis or another painful condition, he or she is often given one of the newer pain relievers -- Bextra and Celebrex.
But new research shows these newer pain relievers, known as Cox-2 inhibitors, may be no safer on the stomach than older anti-inflammatory drugs for people taking Coumadin.
The findings aren't all bad news. The study showed a much lower frequency of bleeding than had been expected.
This new study compared patients taking the blood thinner Coumadin who also regularly took Celebrex or Vioxx (before it was removed from the market), with patients who took Coumadin plus an older anti-inflammatory drug. The two groups had the same risk of being hospitalized for stomach bleeding.
The risk was just 0.3% after three months of treatment, however -- much lower than the 1% to 7% that had been predicted by the researchers.
Preliminary Findings
Until last fall, the Cox-2 inhibitors, which included Vioxx, Celebrex, and Bextra, were widely considered to be safer alternatives to traditional anti-inflammatory drugs like ibuprofen and naproxen.
But studies showing an increased risk of heart attacks among Vioxx users led Merck to take the drug off the market in September. Similar concerns have also been raised about Celebrex and Bextra, which are still widely prescribed.
While their cardiovascular safety remains a topic of heated debate, the stomach safety benefits of the Cox-2 inhibitors have gone largely unquestioned until now. The new research is published in the Jan. 24 issue of the Archives of Internal Medicine.
Researcher Marisa Battistella, PharmD, acknowledges that her findings need to be confirmed in studies of stronger design. Her study included just 24 patients with stomach bleeding who had taken a traditional prescription anti-inflammatory and just 48 patients with stomach bleeding who took Celebrex or Vioxx.
She says, however, that the study offers early evidence that Cox-2 inhibitors are no safer than traditional anti-inflammatory drugs for patients at risk for stomach problems.
"Physicians who prescribe Cox-2 inhibitors need to monitor these patients very, very closely," she tells WebMD.
It's important to note that the average age of the study patients was nearly 80 years old. Older patients have a higher risk of problems such as stomach bleeding. The stomach risk of Cox-2 drugs and the older drugs may be less in younger adults.
Weighing Risks and Benefits
Mark J. Alberts, MD, who directs the stroke program at Northwestern University, says the low frequency of bleeding among the study participants taking Coumadin can be seen as reassuring. He points out that some studies have shown stomach bleeding rates of 1% to 2% a year in patients taking Coumadin alone.
"When you take any medication you have to weigh the risks and benefits," he says. "But this study suggests that you can take [Coumadin] with these pain relievers and have a relatively low risk of hemorrhage."
University of Texas Southwestern Medical Center rheumatologist Scott Zashin, MD, says he would be reluctant to prescribe either a Cox-2 inhibitor or a traditional anti-inflammatory to a patient on a blood thinner such as Coumadin.
"Most rheumatologists would feel the same way, but I don't know if that is true among general practitioners," he says. "It may be that the marketing surrounding these drugs has convinced some people that they are safe to use in patients who have a very high risk for bleeding."
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