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Warnings About Medications' Risks Add Worry to Pain

By Shankar Vedantam
Washington Post Staff Writer
Thursday, December 23, 2004; Page A01

Paula Frazier's family is terrified that the Celebrex she has been taking for arthritis could kill her -- the homemaker from Denton, Tex., has a family history of heart disease, and a study last week suggested the drug may increase heart problems among some patients.

Jonathan Schaffer, an orthopedic surgeon at the Cleveland Clinic in Ohio, knows that many of his patients are panicked after the spate of recent warnings about popular pain-relieving drugs, but he is worried about himself, too: A tennis enthusiast who plays three nights a week, Schaffer takes nonprescription Aleve after each match. On Tuesday, he learned that federal researchers had halted a study because it indicated Aleve might increase the risk of heart attacks and strokes.

At the Del Lago Pharmacy in Wilmette, Ill., Peggy Coha examines the ibuprofen, which is a nonsteroidal anti-inflammatory drug, or NSAID. The NSAID Aleve has been linked to an increased risk of heart attack or stroke. (Tannen Maury -- Bloomberg News)

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In the District, Linda Hannick says she has had trouble climbing down stairs since she was forced to go off Vioxx when the drug was withdrawn in September because of serious safety concerns. Hannick obtained a 10-day supply through a friend who had extra tablets and is now wondering whether she can get the drug overseas and bring it legally into the United States.

From coast to coast, warnings about several popular anti-inflammatory painkillers are triggering confusion and anxiety. Millions of people have come to depend on these medications, and the steady drumbeat of bad news has forced doctors to retreat from one drug after another. Some are frustrated and angry.

"People are saying the whole class of medicines should be thrown out," said David Borenstein, a D.C. rheumatologist. "Well, they should come and live in my shoes and see all the patients I have with arthritis. Going back to medicines we used a decade or two ago is not a step forward."

The safety concerns about the medications, which now include newer drugs known as COX-2 inhibitors and older nonsteroidal anti-inflammatory drugs, or NSAIDs, have come from a range of sources, and the data have sometimes been contradictory. The study finding an increased risk associated with Aleve, for example, found no increased risk associated with Celebrex.

"What does a 70-year-old person [taking anti-inflammatory drugs] to prevent Alzheimer's disease have to do with a 50-year-old person with rheumatoid arthritis who has pain every day?" Borenstein asked. "To say it applies in the same way and has the same risk is ludicrous."

But other medical experts disagreed and said the concerns about drugs such as Vioxx and Celebrex are serious.

"We never believed they were safer to prescribe than the older" drugs such as ibuprofen and aspirin, said Laura Marshall, a spokeswoman for Kaiser Permanente, a nonprofit HMO company that serves more than 8 million Americans. "If there is a lesson to be learned, it is that just because something is newer and costlier doesn't make it better."

Janet Woodcock, acting deputy commissioner for operations at the Food and Drug Administration, said the public had to be alerted about the risks, even if experts do not yet fully understand the biological mechanisms.

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