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Vioxx Safety Debate Renewed After FDA Report

Finds higher risk for heart problems in higher doses

FRIDAY, Aug. 27, 2004 (HealthDayNews) -- A new study linking high doses of Vioxx to an increased risk of heart attacks and sudden cardiac deaths has re-ignited a running debate about the safety of the arthritis drug.

The study of 40,500 people enrolled in Kaiser Permanente, the nation's largest health management organization, found that heart attack rates and sudden cardiac deaths were tripled in patients taking Vioxx in doses higher than 25 milligrams a day compared to those taking a competing drug, Celebrex.

The study was done by personnel at the U.S. Food and Drug Administration, who said that "this and other studies cast serious doubt on the safety" of Vioxx and that Celebrex "may be safer."

Both drugs are members of a family called cox-2 inhibitors, designed to reduce the risk of gastrointestinal damage caused by other arthritis drugs. The previous studies cited in the FDA report, finding a higher risk of heart attack and similar problems in patients taking Vioxx, have caused other health insurers to place limits on its use.

"Vioxx is a non-preferred medication," said Amy Tulkington, a spokeswoman for the heath insurer Cigna HealthCare. "We cover it only for patients who cannot tolerate traditional medications. The decision on which drug to use is left to the physician."

At Aetna, Inc., the third-largest American health insurer, Vioxx is the subject of a continuing study that was started when reports of increased heart risk were published a year ago, said spokesman Jon Sandberg.

"We have launched a study of our membership data bank, analyzing medical records," he said.

Meanwhile, Aetna's policy is to have doctors first try to prescribe one of the older class of arthritis medications, nonsteroidal anti-inflammatory drugs (NSAIDs), Sandberg said.

At Aetna as well as at Cigna, "Vioxx is on our non-preferred list, based on a medical literature review," Sandberg said. But if a cox-2 inhibitor is to be prescribed, Aetna gives preference to Vioxx rather than Celebrex, he said.

Merck & Co., which markets Vioxx, "strongly disagrees" with the findings of the new study, according to a statement by Peter S. Kim, president of Merck Research Laboratories. He faulted the study as being merely observational, looking back at medical records, rather than a randomized, controlled clinical trial, "the gold standard to evaluate safety and efficacy."

Two such controlled studies including more than 2,100 patients found no increased risk of heart attack and similar problems, Kim said.

He also noted that no statistically significant increased risk was found in patients taking less than 25 milligrams a day of Vioxx. That is the recommended dose for rheumatoid arthritis, a condition in which joint damage is caused by an immune system attack against the body's tissues. The recommended starting dose of Vioxx for osteoarthritis, usually caused by the wear and tear of aging, is 12.5 milligrams a day.

More information

Read about the various arthritis drugs, including cox-2 inhibitors, at the Arthritis Foundation.

SOURCES: Amy Tulkington, spokeswoman, Cigna HealthCare, Bloomfield, Conn.; Jon Sandberg, spokesman, Aetna, Inc., Hartford, Conn.; Merck & Co. statement, Aug. 26, 2004
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