Life After Vioxx: What to Do?

Released: 10/4/2004 9:20 AM EDT
Source: University of Michigan Health System

Newswise — The announcement that the drug Vioxx was being pulled from pharmacy shelves because of heart and stroke risks left a lot of pain patients stunned, confused and worried. Some are even wondering if they should abandon medications that are in the same family as Vioxx.

But doctors from the University of Michigan Health System say there are plenty of options to relieve pain and arthritis symptoms, and that patients should talk with their own doctors about what medication or combination of medications is right for them.

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 Mark Fendrick, M.D., a U-M professor of internal medicine who has studied the use of the family of medicines that includes Vioxx, known as non-steroidal anti-inflammatory drugs or NSAIDs.

In 2002, he co-created a pain-medication guideline for doctors that was published in Pharmacy and Therapeutics and adopted by the Michigan Quality Improvement Consortium. It took into account early evidence that Vioxx and its cousins might 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/vioxx.htm)

It's based on research showing that Vioxx and similar prescription drugs, a subset of NSAIDs called Cox-II inhibitors or "superaspirins" , can ease pain just as well as 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. In fact, a warning to that effect was placed on Vioxx years ago.

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."

To see the grid of risk factors and appropriate pain medications, visit http://www.med.umich.edu/opm/newspage/2004/vioxx.htm and scroll down.


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