>Study Suggests Link Between OTC Pain Killers, Heart Problems Monday,
>April 18, 2005
>
>ANAHEIM, Calif. - With prescription drugs Vioxx (search) and Bextra
>already
>pulled from the market, a study has raised disturbing questions about the
>heart safety of long-term use of over-the-counter pain relievers such as
>Advil, Motrin and Aleve.
>
>Smokers in Norway who took such drugs for at least six months had twice
>the
>risk of dying of a heart attack, stroke or other heart-related problem.
>
>The findings came from a study of whether these pain relievers could
>prevent oral cancer. The drugs did, in fact, cut the risk of developing
>oral cancer in half, but the deaths that were prevented were offset by the
>increased risk of dying from cardiovascular disease, according to the
>study, reported Monday at an American Association for Cancer Research
>(search) conference in Anaheim.
>
>The study was relatively small - 908 people - and involved people prone
>to
>heart problems and cancer because they smoked. But specialists said it
>supports the Food and Drug Administration's recent decision to warn about
>long-term use of all such painkillers except aspirin (search).
>
>The findings add to the suspicion that the heart risk extends beyond
>the
>so-called cox-2 drugs - Bextra, Vioxx and Celebrex - to the larger family
>of medications known as non-steroidal anti-inflammatory drugs, or NSAIDs,
>which include naproxen, ibuprofen and virtually all other over-the-counter
>pain relievers except acetaminophen or Tylenol.
>
>In recent months, many doctors have switched patients to these
>over-the-counter medications, believing them to be safer alternatives.
>
>"To the best of our knowledge, these are the first data to support
>putting
>a box warning on NSAIDs, not just cox-2s," said Dr. Andrew Dannenberg, a
>Cornell University scientist who helped do the Norway study.
>
>Vioxx was pulled from the market last fall when a different study,
>testing
>whether it could prevent colon cancer, showed a higher heart disease risk.
>The FDA recently persuaded Pfizer to stop selling Bextra for safety
>reasons, but Pfizer's Celebrex was allowed to remain. Some researchers from
>the new study in Norway have been Pfizer consultants.
>
>Some results from the Norway study were presented in February hearings
>at
>the FDA, but consisted of only one summary slide and "nobody really picked
>up on it," said Dr. Raymond DuBois, a Vanderbilt University cancer expert
>who had no role in the work.
>
>The fresh information presented on Monday should persuade others to
>study
>these over-the-counter drugs in more depth, DuBois 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.
>
>Dr. Jon Sudbo of the Norwegian Radium Hospital in Oslo, who led the
>research, and others wanted to see if NSAIDs could prevent oral cancer,
>since studies showed they could help ward off other types of cancer. 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.
>
>Asked what advice he would give smokers about using such painkillers,
>Sudbo
>replied: "If you think you need them use them, but you have to be careful."
>
>Doctors said the NSAID dose made no difference in risk, but others said
>this should be studied in future experiments.
>
>"There are important uncertainties. One of them is the doses and one is
>what the effect would be in the larger population," said Dr. Michael Thun,
>chief of epidemiology for the American Cancer Society, who had no role in
>the study.
>
>Thun 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.
>
>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 these, 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 large other studies have concluded statins may cut the risk of
>cancer, specialists say there is still not enough evidence yet to recommend
>them for this purpose.