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Patients Urged to Follow Painkiller Labels

U.S. to look at all NSAIDs in clinical trials

TUESDAY, Dec. 21, 2004 (HealthDayNews) -- While government officials and medical experts stress that the newly discovered link between the painkiller Aleve and an increased risk of heart attack and stroke is a preliminary finding, they also say people should talk to their doctor if they plan on taking the drug for long periods of time.

The advice comes on the heels of Monday's revelation that Aleve (naproxen) increased the risk of cardiovascular trouble by 50 percent in elderly patients who were part of a government study on Alzheimer's disease prevention.

That news prompted scientists at the National Institutes of Health (NIH) to say they will review the safety of all such nonsteroidal anti-inflammatory (NSAID) painkillers, including ibuprofen, in all agency-sponsored clinical trials.

Meanwhile, the U.S. Food and Drug Administration issued a statement saying that people taking naproxen should follow the instructions on the drug's label, and not exceed the recommended dosage or take it for longer than 10 days unless their doctor tells them to do so.

Medical experts echoed that advice.

"I agree with the FDA that people who are taking any over-the-counter medication should not take it longer than the duration described on the package insert," said Dr. Mark Fendrick, a professor of internal medicine at the University of Michigan School of Medicine. "Given the media firestorm, it is important for any individual taking any chronic NSAID ... to talk to their physicians about the benefits and perceived risks of the agent they're taking."

While the news about Aleve was troublesome, experts said they felt the danger to periodic users was not high. The drugs were being used in the trials at either higher doses or for longer periods of time than recommended, and for uses "very different from the uses for which these medications are currently approved," an NIH statement said.

"All the people who are taking it short-term probably have little to worry about," said Dr. Stephen Lindsey, section head of rheumatology at the Ochsner Clinic Foundation in New Orleans. "If you've been on something like Naprosyn [the prescription form of naproxen] for several years and you have any history of heart disease in the family or stroke or have risk factors, it would be smart to stop it."

Aleve is the fourth big-selling nonsteroidal anti-inflammatory drug in which potential cardiovascular problems have been discovered recently. Vioxx was pulled off the market in September. Its cousins, Bextra and Celebrex, have also been linked with these adverse events, although both are still available to consumers. Vioxx, Bextra and Celebrex belong to the class of NSAIDs called cox-2 inhibitors.

Officials are concerned that, in addition to Aleve, other commonly used NSAIDs such as Motrin and Advil (both brand names for ibuprofen) may also be shown to have problems.

Aleve, like ibuprofen, is one of a class of drugs called cox-1 inhibitors, which are older than the cox-2 inhibitors. Naproxen has been around in prescription form since 1976 and as a lower-dose, over-the-counter medication since 1994. The current study, which involved about 2,500 participants, was testing whether naproxen or Celebrex could reduce the risk of Alzheimer's disease among elderly patients who had a family history of the disease.

Interestingly, the Celebrex arm of this latest study demonstrated no increased risk.

Ordinarily, the Aleve results announced Monday would not have prompted such publicity, officials noted. "Under normal circumstances, this probably would not have risen to the level of a press briefing, but because of heightened awareness [due to Vioxx and Celebrex], we felt it was very important for transparency's sake to really report these results," NIH Director Dr. Elias Zerhouni said at a Monday press conference. The National Institute on Aging, part of the NIH, is sponsoring the Alzheimer's study.

Experts also cautioned that the results on Aleve were extremely preliminary.

"I wouldn't be surprised if it were hemorrhagic strokes because they have been associated with more GI [gastrointestinal] bleeding, but to implicate a thrombotic or clotting mechanism has left a lot of renowned pharmacologists at a loss. We need to see this study in more detail and other studies before flushing this drug down the toilet," Fendrick said.

"Some of it is a little confusing and conflicting with itself," said Dr. Todd Schlifstein, an assistant professor of rehabilitation medicine at New York University School of Medicine.

"It is confusing and we don't have a lot of information about the NIH trial," agreed Dr. Elinor Mody, a staff rheumatologist at Brigham and Women's Hospital Arthritis Center in Boston. Even FDA officials acknowledged at Monday's press conference that more research and analysis needed to be done.

Mody pointed out that both cox-2 and cox-1 inhibitors can increase the risk of hypertension and kidney troubles, and they need to be used carefully in the elderly and in people with multiple medical problems. "That's always been known," she said.

The cox-2 inhibitors were being taken at higher-than-usual doses in the trials that demonstrated cardiovascular risk. Aleve was being administered at the recommended dose (220 milligrams a day) in the latest trial, but individuals were on it much longer than they would have been had they been taking it for pain.

"If you take it high enough for long enough, that could cause complications not typically seen," Schlifstein said.

Mody said she was more concerned about Celebrex. "We have so much more experience with naproxen. We've been using it since 1976," she said. Nevertheless, "the important thing is that patients talk to their physicians. It has to be done on a case-by-case basis."

Fendrick did note that something positive may result from the latest revelation.

"One of the few silver linings to come out of all this commotion is that it started a dialogue between patients and their doctors regarding whether they need any NSAID at all, and some people may do just as well with non-drug interventions like exercise and physical therapy or shoe inserts," he said.

More information

The U.S. Food and Drug Administration has a statement on naproxen.

SOURCES: Elinor Mody, M.D., staff rheumatologist, Brigham and Women's Hospital Arthritis Center, and instructor, medicine, Harvard Medical School, Boston; Todd Schlifstein, M.D., sports rehabilitation physician, New York University Medical Center, and assistant professor, rehabilitation medicine, New York University School of Medicine, New York City; Stephen Lindsey, M.D., section head, rheumatology, Ochsner Clinic Foundation, New Orleans; Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, Ann Arbor; Dec. 20, 2004, National Institutes of Health news conference
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