Dec. 20, 2004 ANN ARBOR, MI -- Today's announcement that Celebrex, a popular pain drug in the same family as Vioxx, has been found to pose an increased risk of heart problems is bound to leave many pain patients stunned, confused and worried.
The Celebrex news comes just one week after the Food & Drug Administration required the manufacturer of Bextra, another drug in the same family of Cox-II medications, to warn patients of a heart risk associated with that medication.
And of course, Vioxx has been off the market since October, when it was pulled because of mounting evidence that it carried heart risks.
Now, with a shadow cast over the entire Cox-II family of drugs, a University of Michigan expert offers advice for patients who have been taking Celebrex or Bextra, or who stopped taking Vioxx and still aren't sure which drug to choose for pain relief.
“In light of this discouraging news, individuals who are taking either Celebrex or Bextra should immediately contact their physician,” says Mark Fendrick, M.D., a U-M professor of internal medicine who has studied the use of the family of medicines that includes the Cox-IIs, known as non-steroidal anti-inflammatory drugs or NSAIDs.
“Even if these drugs remain on the market, given the availability of other therapies that provide equivalent levels of pain relief and stomach protection, it would be prudent to avoid Celebrex and Bextra until we know for sure about their cardiovascular safety,” Fendrick adds.
The choice may come down to letting your heart or your gut decide – literally. Patients should be treated with medications based in part on their individual risks for heart disease and stomach problems, says Fendrick.
He recently published a pain-medication guideline for doctors that was published in the November issue of the American Journal of Managed Care.
This guideline takes into account the evidence that Vioxx and its cousins likely raise the risk of a heart attack.
“Every patient is different, but there are clear options even in the wake of the Vioxx situation,” says Fendrick. “Patients should work with their clinicians to determine the best combination for them, and to persist until they get relief. No one should have to live with pain and other symptoms that interfere with their daily life.”
Fendrick's guide for treating patients' pain can be boiled down into a four-box grid that takes into account risk for heart disease and risk for gastrointestinal problems caused by NSAIDs. (See: http://www.med.umich.edu/opm/newspage/2004/celebrex.htm)
It's based on research showing that Cox-II drugs or “superaspirins”, can ease pain just as well as – but no better than - other NSAIDs. But Cox-II inhibitors may carry a lower risk of ulcers or of bleeding in the digestive tract than the more traditional NSAIDs, such as ibuprofen or naproxen.
Traditional NSAIDs are available both by prescription and over-the-counter in stores. But either way, they're much less expensive than Cox-II inhibitors.
The grid also takes into account the fact that many people take another NSAID — aspirin — every day to reduce their risk of a heart attack. Taking aspirin with any other NSAID, including Cox-II inhibitors, creates a combined effect that markedly increases the risk of gastrointestinal complication including ulcers and bleeding.
“Most patients and many clinicians are unaware of the fact that adding aspirin to a Cox II inhibitor takes away a great deal, if not all, of the gastrointestinal safety benefit,” says Fendrick. “In fact, a recent national study showed that over 50 percent of Cox II users also take aspirin, and are therefore putting themselves at risk for ulcers and gastrointestinal bleeding.”
Add to that the added heart risk that Cox-II inhibitors appear to carry, and it turns out that people who have suffered heart attacks, chest pains or strokes, or have a high risk for them, probably shouldn't take Cox II drugs at all.
But many patients who take NSAIDs may get benefit by adding a stomach-protecting drug called an acid blocker, or proton pump inhibitor. These are available by prescription (under the names Nexium and Prevacid) or over the counter (sold as Prilosec).
“So, the bottom line is, patients should talk with their clinicians about their pain, their heart risk, and their risk factors for gastrointestinal complication from NSAIDs. Don't assume that what works for one person will work for you, or that risks or side effects are the same for everyone,” says Fendrick. “And no matter what, be frank with your doctor about pain that you're feeling, because in the end you should be able to get relief.”
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