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Warnings put patients in limbo

Mon., Dec. 27, 2004

Safety troubles with Vioxx gave Jay Dudley pains in his arthritic hands – and in his stock portfolio.

The 57-year-old retired firefighter living in Sagle, Idaho, stopped taking the drug after Merck pulled it off the market in late September.

So far, he hasn’t found anything that works as well to relieve pain. His individual retirement account is suffering, too, because he has about 5 percent of it invested in Merck.

“Seems like every time they announce something about these drugs, my stock just takes a dump,” he said.

First it was the arthritis drug Vioxx. Then the U.S. Food and Drug Administration issued a warning about another drug in the same class, Bextra. Then the FDA asked the maker of a third drug in the family, Celebrex, to stop advertising it.

The most recent blow came last Monday. A large study of whether the over-the-counter pain reliever naproxen might help prevent Alzheimer’s disease was halted by the National Institutes of Health. The researchers saw a 50 percent increased risk of heart attacks and strokes among healthy elderly patients taking naproxen daily for up to three years.

Another study that got fewer headlines, published this month in the Archives of Internal Medicine, found that patients were at higher risk of heart attack in the weeks after they stopped taking – yes, stopped taking – ibuprofen, naproxen, aspirin or other anti-inflammatory pain medicines.


So are doctors.

Naproxen, which is not recommended for long-term use, has a nearly 30-year reputation for safety. Its brand names include Anaprox, Naprelan, Naprosyn and Aleve.

Past studies found no heart risk with naproxen, so last week’s news surprised health-care providers.

Galen Goertzen, clinical pharmacy manager for Group Health Cooperative, sympathizes with consumers’ confusion.

“Things that we thought made sense aren’t making sense at the moment,” Goertzen said.

The pharmacist took a phone call from a confused patient Wednesday: his own mother.

He told her to keep taking naproxen for her arthritis.

“I told her, at this point, the data are awfully preliminary,” he said. “We don’t know if this is statistically significant.”

His mother doesn’t have a high risk of heart disease. Goertzen said he would tell patients with a high risk of heart disease to be careful about taking naproxen, especially over long periods.

Some consumers have given up on prescription and over-the-counter drugs. They’re turning instead to dietary supplements, even though supplements have even less safety oversight from the FDA.

Jack Ford, a 64-year-old Valley, Wash., resident, takes a supplement containing glucosamine and chondroitin for arthritis in his shoulders and thumbs. It works for him, he said.

Ford, a construction consultant, said his skepticism is based in a belief that doctors and medical schools are too cozy with drug makers.

“These people are in business to make money,” he said of doctors. “Yes, there are good ones with the purest of motives, but the drug companies still educate them.”

Goertzen, the Group Health pharmacist, said safety warnings need to be weighed against a drug’s benefits by patients in consultation with their doctors. All drugs have risks and come packaged with information detailing side effects and adverse health events.

“Patients need to understand that while we’re talking about relative increases in risk, we’re still talking about very rare events,” Goertzen said. “We hear that a drug increased risk 2.5 times or 3 times, but the overall number is still very small. Unless you’re at high risk for cardiovascular disease, it isn’t something to be panicked about.”

Dr. Jeff Collins of Physicians Clinic of Spokane said he’s less concerned about naproxen’s safety than he is about the safety of Celebrex and Bextra, the COX-2 inhibitors still on the market. He said there is a sound theoretical reason for these drugs’ apparent link to heart attack and stroke. They act on an enzyme in the body in a way that might encourage blood clots.

The older drugs like naproxen, which were considered miracle drugs when they came out in the 1970s, have a longer history of use, he said.


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