Nancy
Well-known member
Here's some more info. on Vioxx. There was an article in the newspaper this morning.
http://jama.ama-assn.org/issues/v286n8/rfull/jsc10193.html
This is a link to the JAMA article
Here's what appeared in the paper this morning
Report Questions Arthritis Drugs
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Story Filed: Tuesday, August 21, 2001 4:07 PM EDT
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 Medical Association, 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.''
On the Net:
JAMA: http://jama.ama-assn.org
http://jama.ama-assn.org/issues/v286n8/rfull/jsc10193.html
This is a link to the JAMA article
Here's what appeared in the paper this morning
Report Questions Arthritis Drugs
--------------------------------------------------------------------------------
Story Filed: Tuesday, August 21, 2001 4:07 PM EDT
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 Medical Association, 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.''
On the Net:
JAMA: http://jama.ama-assn.org
