Press Articles

The Orange County Register (Santa Ana, California), "Some worry 'better' painkillers may have negative side effects"

          Seven years ago, Ruth Carvajal gave up her thriving housecleaning business to battle miserable pain from rheumatoid arthritis. The arthritis had more or less crippled her hands, distorted her posture _ especially along her hips, tortured her every step and robbed her of peaceful sleep.
          Carvajal, 61, of Santa Ana, Calif., tried many medications but eventually found relief only in Celebrex. The prescription drug, along with Vioxx and newcomer Bextra, is among a class of pain medications called cox-2 inhibitors. Hailed as better painkillers when they debuted in 1998, cox-2 inhibitors are now being scrutinized to determine whether they increase risk of heart attacks and whether they pose a lower risk of adverse effects than conventional prescription pain medications.
          The FDA underscored the question of risks in April when it established labeling changes for Vioxx, after a large-scale study on the drug. That study found that Vioxx carried a lower risk of gastrointestinal adverse effects compared with naproxen but also unexpectedly found that those who took Vioxx had a higher risk of a heart attack.

The Associated Press, "New studies add to debate over arthritis drugs and suspected risk of heart attacks"

          Three new studies are adding to a raging debate over whether the popular arthritis pain reliever Vioxx increases the risk of heart attack.
          The editor of the Archives of Internal Medicine, which published the studies in its May 27 edition, says the results offer reassuring evidence that drugs like Vioxx and Celebrex are not bad for the heart.
          But cardiologist Dr. Eric Topol of the Cleveland Clinic said the Food and Drug Administration's order last month for new precautions on Vioxx's label is still warranted.
          Topol took part in an analysis last year of data that showed Vioxx users faced double the risk of serious cardiovascular problems, including stroke and heart attack. He said the newest research leaves the question "far from settled."

USA Today, "Drug dilemma confronts arthritis sufferers"

          Arthritis patients looking for pain relief may start feeling as if they have to choose between two evils: a bleeding ulcer from some drugs, maybe a higher risk of heart attack from another.
          The Food and Drug Administration announced last week that Vioxx -- Merck's blockbuster painkiller, with $ 1.9 billion in sales last year -- would include new information on its label. The FDA said Merck can claim that Vioxx has fewer gastrointestinal (GI) complications than one older non-steroidal anti-inflammatory drug, naproxen. But the FDA also decided that the Vioxx label must mention that it might be linked to an increased risk of heart attack or high blood pressure.
          More than a year ago, an FDA advisory committee recommended adding the heart disease information to Vioxx's label after hearing presentations by agency scientists.

The New York Times, "Merck to Revise Label Information for Vioxx"

          Merck & Company said yesterday that it would revise prescribing information for its Vioxx painkiller to show both cardiovascular risks and a benefit in reducing side effects like ulcers in arthritis patients.
          Merck will include information on higher risks of heart attacks for Vioxx patients, compared with the risk in patients taking an older painkiller, naproxen. The Food and Drug Administration will also allow changes in the drug's label to reflect results from a study showing that Vioxx patients had fewer gastrointestinal side effects than patients on naproxen. Vioxx had sales of $2.6 billion last year.