Study casts more doubt on the safety of popular pain killers

Tuesday, April 19th 2005, 8:42 am

By: News On 6

ANAHEIM, Calif. (AP) _ Smokers who regularly took certain popular pain killers cut their risk of developing oral cancer but increased their chances of dying from heart-related problems, according to a study that raises fresh questions about the long-term use of Advil, Motrin and Aleve.

The findings add to the suspicion that the heart risk extends beyond medications like Bextra, Vioxx and Celebrex to the larger family of pain relievers known as non-steroidal anti-inflammatory drugs, or NSAIDs. These include brands of ibuprofen and virtually all other over-the-counter pain pills except acetaminophen or Tylenol.

Short-term use of these medications _ two weeks or less _ for headaches or other pain is still considered safe.

However, the study of smokers in Norway is the first evidence to support the recent federal Food and Drug Administration decision to warn about long-term use of all of these drugs except aspirin.

Results were presented Monday at an American Association for Cancer Research meeting in Anaheim.

Many doctors have switched patients to over-the-counter NSAIDs since the prescription drugs Vioxx and Bextra were pulled from the market, believing them to be safer.

Doctors in Norway wanted to see whether NSAIDs could prevent oral cancer because other work suggested they helped ward off other cancers.

They chose more than 3,000 people at high risk for oral cancer because of their smoking habits from the Norwegian Cancer Registry, a database of more than 123,000 people.

Over 20 years, 454 of them developed oral cancer, and they were compared with 454 similar people who did not develop the disease. Of these 908 people, 263 had used NSAIDs daily for at least six months. They had a two-thirds lower risk of developing oral cancer, but scientists were puzzled because deaths were not lower.

A deeper look revealed that the NSAID users were dying at twice the rate of the others from heart-related problems. There were 42 cardiovascular deaths among the 263 painkiller users and 41 deaths among the much larger group of 562 people who had never taken such drugs.

Risk was highest among ibuprofen users, who were nearly three times more likely to die of cardiovascular disease than non-NSAID users. Aspirin was the only NSAID that did not seem to raise the risk, but the numbers of aspirin users in the study were small.

Scientists were astonished at the results.

``Many of these deaths could have been avoided if we'd monitored these patients for cardiovascular disease, but nobody thought of it'' because the risk wasn't known, said the lead researcher, Dr. Jon Sudbo of the Norwegian Radium Hospital in Oslo.

He and some of his colleagues have been consultants for Pfizer Inc., which makes the NSAID Celebrex.

Dr. Raymond DuBois, a Vanderbilt University cancer expert who had no role in the work, said the results should persuade others to study over-the-counter drugs in more depth.

Dr. Michael Thun, chief epidemiologist for the American Cancer Society, said he would propose a larger study on over-the-counter NSAIDs using the cancer society's huge database, which contains information on more than 1.2 million Americans.

``There are important uncertainties'' about the results from just one study in people at high risk of cancer and heart disease because they smoke versus the general population, he said.

Oral cancer is a deadly and disfiguring disease that is an especially big problem in Asia. Worldwide, about 275,000 cases and 127,000 deaths occur each year. In the United States, about 29,370 new cases and 7,320 deaths are expected this year.

In other news at the conference, a large study suggested that cholesterol-lowering statin drugs might help prevent the most serious types of prostate cancer _ those that kill or spread throughout the body.

Men who took statins had half the risk of advanced prostate cancer as men who did not take such drugs, reported Elizabeth Platz of Johns Hopkins University, who did the study with Harvard University researchers and the National Cancer Institute.

It involved 34,438 men in the Health Professionals Follow-up Study, which has been going on at Harvard since 1986. None of the men had prostate cancer at the start of this particular study in 1990, but 2,074 developed it over the next decade. Of those, 283 were advanced, including 206 that were fatal or had spread widely in the body.

While statins cut the chances of this, they made no difference in the risk of developing cancer that remains confined to the prostate. Although several other large studies have concluded statins may cut the risk of cancer, specialists say there is still not enough evidence yet to recommend them for that purpose.