For Former Vioxx Users, Celebrex May Be an Option

Sept. 12, 2006 — -- The painkiller Celebrex may be safe for some patients who suffer from chronic bone and joint pain, even though similar drugs come with dangerous side effects, according to new research that will be published in an upcoming issue of the Journal of the American Medical Association.

The Journal's editors wanted to release the research before it was published because of its importance to the public, according to a press release.

Celebrex, also known as Celecoxib, is one of several drugs known as cox-2 inhibitors, nonsteroidal anti-inflammatory drugs, or NSAIDs. More than 30 million people worldwide take daily doses of NSAIDs, which include over-the-counter Tylenol, to treat inflammation and pain. (Many NSAIDs are sold over-the-counter, except for all the cox-2 inhibitors, which are prescription-only medications.)

The safety of cox-2 inhibitors has been a big topic ever since one of the most popular of those drugs, Vioxx, was pulled from the shelves in 2004 because studies showed it increased the risk of heart attacks and strokes. The upcoming Journal contains two review studies that take a second look at the safety of Vioxx and other NSAIDs.

The first study reviewed 114 different trials of cox-2 inhibitors that involved 116,094 people. Researchers concluded that Vioxx did indeed increase the risk of kidney and heart rhythm problems. However, in the same review, small doses of Celebrex did not cause these problems. This suggests that not all cox-2 inhibitors are unsafe.

The second study looked back at other trials that had included cox-2 inhibitors and other NSAIDs. Again, the researchers found that Celebrex was less dangerous than the other cox-2 inhibitors.

"It is good to see that there is no significant increased risk in the other drugs in the class [cox-2 inhibitors]," said Dr. Steven Nissen, cardiologist at the Cleveland Clinic and president of the American College of Cardiologists.

Nissen has an ongoing study, with funding from Pfizer, the makers of Celebrex, which will include 21,000 patients and will compare Celebrex to ibuprofen and naproxen.

Most doctors agreed that Celebrex could be used in a small group of patients who are at very low risk for heart attack and stroke and have not benefited from other painkillers. Others are more cautious because many cox-2 inhibitors have produced serious side effects.

"Celebrex should be considered if all other treatments fail, and then it should be used only in low doses and for short periods of time," said Dr. Kurt Furberg of the Wake Forest University Department of Public Health.

Furberg is a former member of the Food and Drug Administration's drug safety advisory committee.

"[Cox-2 inhibitors] should be restricted," he said. "Naproxen ought to be the drug of choice."

Almost all the other NSAIDs, such as Aleve and Advil, are relatively safe, the studies found. But the studies also found that one traditional pain medication, Diclofenac, might also increase risk of heart attack and stroke.

"One could consider withdrawing a few other nonselective NSAIDs [like Diclofenac]," said Furberg.

So what are patients supposed to do when they look for an anti-inflammatory painkiller?

Naproxen, sold as Aleve, is a safe and effective treatment, according to the studies. Doctors also recommend ibuprofen (Advil/Motrin) and acetomenophen (Tylenol) to treat joint pain.

While Aleve is safe for pain relief, it does not protect heart vessels against disease as many doctors had thought.