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New Doubts Cast on Painkillers -- Over-Counter Drugs Tied to Higher Heart Risks in Norwegian Study

Posted on: Wednesday, 20 April 2005, 12:00 CDT

ANAHEIM, Calif. - With prescription drugs Vioxx 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 or other heart-related problem.

The findings came from a study of whether these pain relievers could prevent oral cancer. The drugs did cut the risk of developing oral cancer in half, but the deaths that were prevented were offset by the increased risk of dying of cardiovascular disease, according to the study, reported Monday at an American Association for Cancer Research 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.

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 known as nonsteroidal 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 safer.

"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 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 Norway study 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 with no role in the work.

The data presented on Monday should persuade others to study these over-the-counter drugs in more depth, he said.

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Pain-reliever facts

Associated Press

The issue: The removal of Vioxx and Bextra from the market because of heart risks has led to worries that other pain relief medications carry similar danger.

What: A study on preventing oral cancer in smokers in Norway examined their use of a variety of painkillers.

Results: Those taking daily doses of nonsteroidal anti- inflammatory drugs, or NSAIDs, had double the risk of dying of heart- related problems.

Which drugs: Nonprescription NSAIDS include ibuprofen (brand names include Motrin, Advil and Medipren), naproxen (Aleve) and ketoprofen (Orudis, Actron). No additional risk was seen from aspirin or from Tylenol, which is not an NSAID.

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Source: Commercial Appeal, The

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