The following articles are from John Hopkins Medical at www.intelihealth.com

http://ipn.intelihealth.com/IPN/ihtIPN?st=23883&t=7223&c=331704

Report Suggests Heart Link With Celebrex, Vioxx, But Critics Say More Research Needed

August 21, 2001

CHICAGO (AP) - The popular and heavily promoted new arthritis drugs Vioxx and Celebrex have been linked by researchers to a small but troubling increase in the risk of heart attacks and strokes. Critics say the analysis is flawed and no cause for alarm.

Still, many agree the issue needs to be studied because millions of people take the drugs, known as cox-2 inhibitors.

The researchers analyzed four studies that were not designed to examine the drugs' effects on the heart. Until such research is done, doctors should use caution in prescribing them to patients with heart disease, said Dr. Eric Topol, co-author of the analysis and chairman of cardiovascular medicine at the Cleveland Clinic.

Topol said he uses such medication himself for knee arthritis, "but if I had known heart disease, I would be concerned."

The analysis, published in Wednesday's Journal of the American Medicine, included a study that looked at the gastrointestinal side effects in 8,076 patients taking Vioxx or the pain reliever naproxen. Vioxx patients faced double the risk of serious cardiovascular problems, including strokes and heart attacks, though only 111 Vioxx patients had them. Two smaller Vioxx studies also suggested potential heart problems, Topol said.

Also, a study of 7,968 patients using Celebrex or two other pain relievers showed a slight but statistically insignificant increase in cardiovascular side effects with Celebrex, but the numbers were "trending in the wrong direction," Topol said.

An advisory panel warned the Food and Drug Administration in February of the Vioxx-naproxen study and said Vioxx should carry a warning label about potential cardiovascular risks. The FDA has not yet ruled on that recommendation.

Cox-2 drugs are touted for their ability to relieve pain without the gastrointestinal upsets of aspirin and other medications and are among the most popular medicines worldwide. They are expected to generate $6 billion in sales and 200 million prescriptions in the United States alone this year, Topol said. Celebrex and Vioxx are widely advertised on television and in magazines.

Skeptics said the researchers presented incomplete and misleading data.

"It's inappropriate at this point to rush to a conclusion that these drugs pose a serious cardiovascular risk," said Dr. Thomas Schnitzer, a Northwestern University rheumatologist. The analysis "is very far from proof."

Vioxx manufacturer Merck & Co. and Pharmacia Corp., which makes Celebrex, disputed the analysis and said their drugs are safe.

Dr. Laura Demopoulous, Merck's senior director of cardiovascular clinical research, noted that the Vioxx study involved patients with rheumatoid arthritis, a disease that raises the risk of heart trouble. She also said the results may reflect naproxen's potential heart-friendly benefits rather than any negative effects from Vioxx.

Dr. Steve Geis, Pharmacia vice president for clinical research, said comparing studies involving different drugs and patients with different types of arthritis "is misleading and it is not quite accurate."

Dr. John Klippel, medical director for the Arthritis Foundation, said some of the studies included patients taking aspirin, which can benefit the heart by thinning the blood. Still, Klippel said the analysis raises important questions.

"We have to reassure people that these drugs are safe, yet there does seem to be some caution, particularly for people who are at increased risk of cardiovascular disease," he said.

Dr. Leslie Crofford, a University of Michigan rheumatologist, said the analysis will force doctors to consider such issues when prescribing arthritis medication.

While the new drugs might be better for patients at risk for gastrointestinal problems, "there's absolutely no data that these drugs are better for arthritis than traditional" pain relievers, she said. "They're good drugs, and for the right people, they can make a big difference. But they're not for everybody."

Report Suggests Heart Link With Celebrex, Vioxx, But Critics Say More Research Needed

August 21, 2001

CHICAGO (AP) - The popular and heavily promoted new arthritis drugs Vioxx and Celebrex have been linked by researchers to a small but troubling increase in the risk of heart attacks and strokes. Critics say the analysis is flawed and no cause for alarm.

Still, many agree the issue needs to be studied because millions of people take the drugs, known as cox-2 inhibitors.

The researchers analyzed four studies that were not designed to examine the drugs' effects on the heart. Until such research is done, doctors should use caution in prescribing them to patients with heart disease, said Dr. Eric Topol, co-author of the analysis and chairman of cardiovascular medicine at the Cleveland Clinic.

Topol said he uses such medication himself for knee arthritis, "but if I had known heart disease, I would be concerned."

The analysis, published in Wednesday's Journal of the American Medicine, included a study that looked at the gastrointestinal side effects in 8,076 patients taking Vioxx or the pain reliever naproxen. Vioxx patients faced double the risk of serious cardiovascular problems, including strokes and heart attacks, though only 111 Vioxx patients had them. Two smaller Vioxx studies also suggested potential heart problems, Topol said.

Also, a study of 7,968 patients using Celebrex or two other pain relievers showed a slight but statistically insignificant increase in cardiovascular side effects with Celebrex, but the numbers were "trending in the wrong direction," Topol said.

An advisory panel warned the Food and Drug Administration in February of the Vioxx-naproxen study and said Vioxx should carry a warning label about potential cardiovascular risks. The FDA has not yet ruled on that recommendation.

Cox-2 drugs are touted for their ability to relieve pain without the gastrointestinal upsets of aspirin and other medications and are among the most popular medicines worldwide. They are expected to generate $6 billion in sales and 200 million prescriptions in the United States alone this year, Topol said. Celebrex and Vioxx are widely advertised on television and in magazines.

Skeptics said the researchers presented incomplete and misleading data.

"It's inappropriate at this point to rush to a conclusion that these drugs pose a serious cardiovascular risk," said Dr. Thomas Schnitzer, a Northwestern University rheumatologist. The analysis "is very far from proof."

Vioxx manufacturer Merck & Co. and Pharmacia Corp., which makes Celebrex, disputed the analysis and said their drugs are safe.

Dr. Laura Demopoulous, Merck's senior director of cardiovascular clinical research, noted that the Vioxx study involved patients with rheumatoid arthritis, a disease that raises the risk of heart trouble. She also said the results may reflect naproxen's potential heart-friendly benefits rather than any negative effects from Vioxx.

Dr. Steve Geis, Pharmacia vice president for clinical research, said comparing studies involving different drugs and patients with different types of arthritis "is misleading and it is not quite accurate."

Dr. John Klippel, medical director for the Arthritis Foundation, said some of the studies included patients taking aspirin, which can benefit the heart by thinning the blood. Still, Klippel said the analysis raises important questions.

"We have to reassure people that these drugs are safe, yet there does seem to be some caution, particularly for people who are at increased risk of cardiovascular disease," he said.

Dr. Leslie Crofford, a University of Michigan rheumatologist, said the analysis will force doctors to consider such issues when prescribing arthritis medication.

While the new drugs might be better for patients at risk for gastrointestinal problems, "there's absolutely no data that these drugs are better for arthritis than traditional" pain relievers, she said. "They're good drugs, and for the right people, they can make a big difference. But they're not for everybody."

Report Suggests Heart Link With Celebrex, Vioxx, But Critics Say More Research Needed August 21, 2001 CHICAGO (AP) - The popular and heavily promoted new arthritis drugs Vioxx and Celebrex have been linked by researchers to a small but troubling increase in the risk of heart attacks and strokes. Critics say the analysis is flawed and no cause for alarm.

Still, many agree the issue needs to be studied because millions of people take the drugs, known as cox-2 inhibitors.

The researchers analyzed four studies that were not designed to examine the drugs' effects on the heart. Until such research is done, doctors should use caution in prescribing them to patients with heart disease, said Dr. Eric Topol, co-author of the analysis and chairman of cardiovascular medicine at the Cleveland Clinic.

Topol said he uses such medication himself for knee arthritis, "but if I had known heart disease, I would be concerned."

The analysis, published in Wednesday's Journal of the American Medicine, included a study that looked at the gastrointestinal side effects in 8,076 patients taking Vioxx or the pain reliever naproxen. Vioxx patients faced double the risk of serious cardiovascular problems, including strokes and heart attacks, though only 111 Vioxx patients had them. Two smaller Vioxx studies also suggested potential heart problems, Topol said.

Also, a study of 7,968 patients using Celebrex or two other pain relievers showed a slight but statistically insignificant increase in cardiovascular side effects with Celebrex, but the numbers were "trending in the wrong direction," Topol said.

An advisory panel warned the Food and Drug Administration in February of the Vioxx-naproxen study and said Vioxx should carry a warning label about potential cardiovascular risks. The FDA has not yet ruled on that recommendation.

Cox-2 drugs are touted for their ability to relieve pain without the gastrointestinal upsets of aspirin and other medications and are among the most popular medicines worldwide. They are expected to generate $6 billion in sales and 200 million prescriptions in the United States alone this year, Topol said. Celebrex and Vioxx are widely advertised on television and in magazines.

Skeptics said the researchers presented incomplete and misleading data.

"It's inappropriate at this point to rush to a conclusion that these drugs pose a serious cardiovascular risk," said Dr. Thomas Schnitzer, a Northwestern University rheumatologist. The analysis "is very far from proof."

Vioxx manufacturer Merck & Co. and Pharmacia Corp., which makes Celebrex, disputed the analysis and said their drugs are safe.

Dr. Laura Demopoulous, Merck's senior director of cardiovascular clinical research, noted that the Vioxx study involved patients with rheumatoid arthritis, a disease that raises the risk of heart trouble. She also said the results may reflect naproxen's potential heart-friendly benefits rather than any negative effects from Vioxx.

Dr. Steve Geis, Pharmacia vice president for clinical research, said comparing studies involving different drugs and patients with different types of arthritis "is misleading and it is not quite accurate."

Dr. John Klippel, medical director for the Arthritis Foundation, said some of the studies included patients taking aspirin, which can benefit the heart by thinning the blood. Still, Klippel said the analysis raises important questions.

"We have to reassure people that these drugs are safe, yet there does seem to be some caution, particularly for people who are at increased risk of cardiovascular disease," he said.

Dr. Leslie Crofford, a University of Michigan rheumatologist, said the analysis will force doctors to consider such issues when prescribing arthritis medication.

While the new drugs might be better for patients at risk for gastrointestinal problems, "there's absolutely no data that these drugs are better for arthritis than traditional" pain relievers, she said. "They're good drugs, and for the right people, they can make a big difference. But they're not for everybody."

Report Suggests Heart Link With Celebrex, Vioxx, But Critics Say More Research Needed August 21, 2001 CHICAGO (AP) - The popular and heavily promoted new arthritis drugs Vioxx and Celebrex have been linked by researchers to a small but troubling increase in the risk of heart attacks and strokes. Critics say the analysis is flawed and no cause for alarm.

Still, many agree the issue needs to be studied because millions of people take the drugs, known as cox-2 inhibitors.

The researchers analyzed four studies that were not designed to examine the drugs' effects on the heart. Until such research is done, doctors should use caution in prescribing them to patients with heart disease, said Dr. Eric Topol, co-author of the analysis and chairman of cardiovascular medicine at the Cleveland Clinic.

Topol said he uses such medication himself for knee arthritis, "but if I had known heart disease, I would be concerned."

The analysis, published in Wednesday's Journal of the American Medicine, included a study that looked at the gastrointestinal side effects in 8,076 patients taking Vioxx or the pain reliever naproxen. Vioxx patients faced double the risk of serious cardiovascular problems, including strokes and heart attacks, though only 111 Vioxx patients had them. Two smaller Vioxx studies also suggested potential heart problems, Topol said.

Also, a study of 7,968 patients using Celebrex or two other pain relievers showed a slight but statistically insignificant increase in cardiovascular side effects with Celebrex, but the numbers were "trending in the wrong direction," Topol said.

An advisory panel warned the Food and Drug Administration in February of the Vioxx-naproxen study and said Vioxx should carry a warning label about potential cardiovascular risks. The FDA has not yet ruled on that recommendation.

Cox-2 drugs are touted for their ability to relieve pain without the gastrointestinal upsets of aspirin and other medications and are among the most popular medicines worldwide. They are expected to generate $6 billion in sales and 200 million prescriptions in the United States alone this year, Topol said. Celebrex and Vioxx are widely advertised on television and in magazines.

Skeptics said the researchers presented incomplete and misleading data.

"It's inappropriate at this point to rush to a conclusion that these drugs pose a serious cardiovascular risk," said Dr. Thomas Schnitzer, a Northwestern University rheumatologist. The analysis "is very far from proof."

Vioxx manufacturer Merck & Co. and Pharmacia Corp., which makes Celebrex, disputed the analysis and said their drugs are safe.

Dr. Laura Demopoulous, Merck's senior director of cardiovascular clinical research, noted that the Vioxx study involved patients with rheumatoid arthritis, a disease that raises the risk of heart trouble. She also said the results may reflect naproxen's potential heart-friendly benefits rather than any negative effects from Vioxx.

Dr. Steve Geis, Pharmacia vice president for clinical research, said comparing studies involving different drugs and patients with different types of arthritis "is misleading and it is not quite accurate."

Dr. John Klippel, medical director for the Arthritis Foundation, said some of the studies included patients taking aspirin, which can benefit the heart by thinning the blood. Still, Klippel said the analysis raises important questions.

"We have to reassure people that these drugs are safe, yet there does seem to be some caution, particularly for people who are at increased risk of cardiovascular disease," he said.

Dr. Leslie Crofford, a University of Michigan rheumatologist, said the analysis will force doctors to consider such issues when prescribing arthritis medication.

While the new drugs might be better for patients at risk for gastrointestinal problems, "there's absolutely no data that these drugs are better for arthritis than traditional" pain relievers, she said. "They're good drugs, and for the right people, they can make a big difference. But they're not for everybody."

http://www.intelihealth.com/IH/ihtIH/EMIHC000/333/8011/331664.html

Cholesterol Drug Warnings Urged August 21, 2001 WASHINGTON (AP) - Nearly two weeks after a popular cholesterol-lowering drug was pulled off the market for causing deadly muscle destruction, a consumer group charged Monday that five similar medications have killed an additional 81 people.

Public Citizen petitioned the government to force manufacturers to give special warning brochures to the millions of Americans who take those medicines - statins - telling them to quit the pills at the first sign of muscle pain or weakness.

Statins dramatically lower cholesterol and reduce patients' risk of heart attacks.

"Most people taking these drugs aren't aware that they could sustain serious muscle damage and could even die," said Dr. Sidney Wolfe of Public Citizen's Health Research Group.

"Serious muscle and kidney damage, and potentially death, may be averted only if the patients taking statins stop the drugs at the first sign of muscle pain or weakness," Wolfe wrote the Food and Drug Administration Monday.

The FDA disputed Wolfe's death count, saying its own investigation last year uncovered just 18 deaths that could be linked to the five statins on the U.S. market - Lipitor, Mevacor, Pravachol, Zocor and Lescol.

But the agency will consider Wolfe's request for stiffer warnings.

Pfizer Inc. already has asked the FDA to approve a brochure written in layman's language that would accompany every bottle of the top-selling statin Lipitor, explaining the risk.

Wolfe's petition comes almost two weeks after one statin, Baycol, was pulled off the market when the FDA linked it to 31 U.S. deaths from a side effect called rhabdomyolysis. That's a rare but life-threatening condition in which muscle cells are destroyed. In severe cases, it leads to kidney failure.

Every statin has been linked to rare reports of a muscle side effect, and their labels carry that warning.

Wolfe analyzed FDA records to uncover 772 cases of rhabdomyolysis since 1997 among the six statins sold in this country. Half - 387 cases - were caused by Baycol alone, explaining why Bayer pulled it off the market.

But Wolfe said he found another 385 rhabdomyolysis cases among users of the other five statins still sold, including 81 deaths dating back to 1987, when the first of those drugs hit the market.

That's still a rare risk, considering 8 million Americans are estimated to use statins. But Wolfe argues that severe muscle destruction and death are preventable if patients are aware of the early warning signs.

He urged the FDA to put stronger warnings on the statins' labels, to write every U.S. physician telling them about the risk, and to mandate that every patient get a brochure with each bottle telling them to stop the pills and call a doctor if they suffer muscle symptoms.

A closer look at the FDA's reports shows duplicates and patients who actually died of other causes, leading federal health officials to link just 18 rhabdomyolysis deaths to statins during an investigation last year, said FDA's Dr. John Jenkins.

Merck & Co., maker of Zocor and Mevacor, says it provides Zocor users a layman's explanation of the muscle side effect on its Internet site.

Bristol-Myers Squibb is seeking to capitalize on Baycol's departure with full-page newspaper ads of Pravachol that mention the muscle risk, but company spokesmen didn't return calls seeking comment Monday.

Lescol-maker Novartis maintained the risk is small and that patients are appropriately warned.

-- suzy (itssuzy2@aol.com), August 22, 2001