Consumer Confusion Persists on Painkillers' Safety

Some patients quit cox-2 therapy; others have cut back as questions remain

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HealthDay Reporter

MONDAY, March 21, 2005 (HealthDay News) -- Following months of public wrangling over the safety of cox-2 inhibitors and even with a federal advisory panel's endorsement to keep them on the market, consumers are still as confused as ever about these powerful painkillers.

Recent surveys show many have cut back or stopped taking the medications because they're uncertain whether the heart risks seen with these drugs are outweighed by the benefits.

In one poll of back pain patients, almost two-thirds said they had stopped taking cox-2 medications. Forty-two percent of them said they switched to other pain medications, 9 percent substituted non-drug pain relievers and 13 percent were going without any medication, a Spine-health.com survey found.

Separately, Boston's Rippe Lifestyle Institute released survey results showing that close to half the arthritis patients they questioned have stopped or cut back the use of pain relievers because they are confused about which treatment options are safe.

"My sense would be that the public understands that this continues to be an important class of drugs," said Dr. John H. Klippel, president and CEO of the Arthritis Foundation.

People simply want to be informed about the potential risks so they can make choices, he added.

The American Heart Association (AHA), in a science advisory just issued Monday, has a new recommendation for those using cox-2 inhibitors and all other medications in the class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs).

The AHA advice: use the drug with the fewest known risks.

That means that cox-2s like Celebrex (celecoxib) and Bextra (valdecoxib) should be "held in reserve, generally for short-term use," according to a prepared statement from Dr. Joel S. Bennett, a hematologist and a member of the writing group that drafted the advisory. The new recommendations are published in this week's issue of the journal Circulation.

Merck's move to pull Vioxx off the market last September initially boosted the market share of rival products, as doctors switched Vioxx patients to Celebrex or Bextra and started new patients on those competing cox-2 therapies, according to IMS Health, a pharmaceutical information company.

But by year-end, the entire market began to shrink. Cox-2 prescriptions slid nearly 6 percent to 50,742 in 2004, from 53,890 the prior year, the company reported.

Final figures for January and February are not yet available. And it's anyone's guess how prescribing patterns may have changed in the last month, following the U.S. Food and Drug Administration advisory panel's decision to green-light the drugs but with warning labels.

"It's March that's going to be more interesting to all of us," said Dr. A. Mark Fendrick, a professor of health management and policy at the University of Michigan's School of Public Health.

Given the relatively positive findings of the panel, Fendrick said he wouldn't be surprised to see an initial uptake in cox-2 prescriptions or at least a slowing of their decline.

Dr. Scott D. Solomon, the director or noninvasive cardiology at Brigham and Women's Hospital, had a similar reaction: "Paradoxically, the findings of the FDA panel last month may have attenuated what many considered an initial overreaction to the original news [regarding the safety of cox-2 drugs]."

Cox-2 inhibitors work to reduce pain and inflammation, just like traditional NSAIDs -- including aspirin, Advil, Motrin and Aleve -- but are designed to be safer to the stomach.

Yet patients tend to lump all NSAIDs together, failing to distinguish between traditional NSAIDs and the newer cox-2 drugs, said pain researcher Allan Basbaum, chairman of the department of anatomy at the University of California, San Francisco.

"Anecdotally, I know of friends who have decided not to use ibuprofen. That's a serious problem," he said. But it may be only temporary, as patients find there are no other good options. "Acetaminophen won't deal with many things that the NSAIDs can handle," he said.

The FDA panel helped make the distinction between cox-2s and other NSAIDs last month when it absolved naproxen of cardiac risk. Naproxen is sold over-the-counter under the brand names Aleve and Naprosyn. But Fendrick fears the message may have gotten lost amid the government's scrutiny of prescription pain relievers.

"It was dragged into the quagmire when it never should have been in the pit," he said.

Yet for people with cardiac risk factors or those taking aspirin to prevent heart attack and stroke, the traditional NSAIDs, such as naproxen, are a better choice than cox-2 inhibitors, Fendrick insisted.

"What I've been saying all along is it's back to the future -- instead of a cox-2, to use an older NSAID plus a proton pump inhibitor (to protect the stomach)," he said.

More information

The Federal Citizen Information Center has more on the risks of cox-2 inhibitors and NSAIDs.

SOURCES: John H. Klippel, M.D., president and CEO, Arthritis Foundation, Atlanta; A. Mark Fendrick, M.D., professor, internal medicine and health management and policy, University of Michigan, Ann Arbor; Scott D. Solomon, M.D., director, noninvasive cardiology, Brigham and Women's Hospital, and associate professor, medicine, Harvard Medical School, Boston; Allan Basbaum, Ph.D., chairman, department of anatomy, University of California, San Francisco; Spine-health.com, Evanston, Ill,; Rippe Lifestyle Institute, Boston, Mass.; IMS Health, Fairfield, Conn.; November 2004 The American Journal of Managed Care; March 21, 2005, American Heart Association advisory

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