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.
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Linda Hannick says she has had trouble climbing down stairs since she was forced to go off Vioxx when the drug was withdrawn in September because of serious safety concerns.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."
Conflicting data
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.
Woodcock said the agency is awaiting further analysis and will look into several other ongoing studies in which the drugs are being tested. The FDA has scheduled an advisory committee meeting in February to review the findings but will release information with public health implications before that, she said.
The drugs under suspicion, some sold by prescription and others over the counter, are used principally by people who have arthritis and other conditions that cause chronic pain. They are also widely used by athletes recovering from injuries -- or even a tough game of tennis.
"We are in a society where we are taught if you have an ache or a pain, take one of these," Schaffer said. The surgeon said his own analysis of the data told him the reported risks are real and have to be grappled with.
'Lots of aches and pains'
Judi Epstein of the District, who has run marathons and has led a very active life, said she is at a loss since the recall of Vioxx. Epstein, 58, was taking it for arthritis and chronic pain. She has been switched to Celebrex but said in an interview that it was not the same.
"I took it five solid years twice a day," she said of Vioxx. Now, "I'm just in a lot of aches and pains. I just went to cross my legs, and it is killing me."
John H. Klippel, president and chief executive of the Arthritis Foundation and a rheumatologist by training, cautioned against overreacting to the safety concerns.
Donna Sweet, a professor of internal medicine at the University of Kansas school of medicine in Wichita and a leader who spoke on behalf of the American College of Physicians, urged patients not to switch medications without consulting a physician.
"The Vioxx was bad enough, and then it led into Bextra and then the Celebrex study," she said. "Patients panic, and people are stopping medications when the risk-benefit ratio is in their favor."
Frazier, 40, the woman in Texas, said she had been bounced from drug to drug with each wave of bad news. She suffers from constant back pain as a result of osteoarthritis and intermittent pain in her hands and feet that doctors have not been able to diagnose.
Vioxx allowed her to function without pain and to lift her 4-year-old son, she said. When that drug was withdrawn, her doctor switched her to Bextra, another COX-2 inhibitor that has recently come under suspicion. Frazier stopped taking Bextra because it was not helping her, and her doctor switched her to Celebrex. Then came the study suggesting a possible increased risk for Celebrex.
"My family thinks I should stop taking it," she said. "They say the pain would come back but I'd be alive. They see it in black and white. What I understand better than my family is that with every benefit there is a side effect, but not everyone gets the side effect."
Frazier's doctor, Dallas rheumatologist Scott Zashin, said he will switch her to Lodine, an older drug.
"I am trying to get patients off medications, encourage aerobic exercise and also restorative sleep," said Zashin, who is the author of the book "Arthritis Without Pain." "If you sleep well, that may decrease your pain. Acupuncture is something I have done with some of my patients."
'Back to square one'
Hannick, 57, a bio-informatics analyst in the District, said she started taking Vioxx four years ago for arthritis. Then, two years ago, a motorist slammed into Hannick's car on a snowy day on the George Washington Memorial Parkway. Hannick saw him coming and turned her steering wheel to avoid hitting the car in front of her -- an altruistic gesture that saved the next car but caused her shoulder to take the brunt of the impact.
Surgery followed. Hannick grew even more dependent on her Vioxx. Her hips hurt after the accident, and she had trouble descending stairs. She was heartbroken when Merck withdrew the drug. Her doctor put her on another medication, but it was not as effective.
"I was back to square one," she said. "My shoulder hurt, my lower back flared up, and everything hurt," she said.
That is when a friend offered her a 10-day supply of Vioxx. That calmed down most of the pain, and Hannick's doctor then put her on yet another medication -- Arthrotec, a combination drug that includes an NSAID.
But Hannick is still in pain. If she had the chance, she would go back on Vioxx "in a minute," she said. "In fact, I am keeping my ears open to see if anybody has any more."
Staff writer Rob Stein contributed to this report.