This week, I talked about osteoarthritis and rheumatoid arthritis. For those out there suffering from OSTEOPOROSIS, you might want to read the following repost from the NY Times Health; and if you would post your opinions on this article, I'd appreciate the feedback. I'm always interested in what you're thinking out there!
October 13, 2010, 4:02 pm
F.D.A. Issues Warning on Bone Drugs, by DUFF WILSON
The Food and Drug Administration issued a warning on Wednesday linking long-term use of popular osteoporosis drugs to an unusual fracture of the thigh bone.
The agency asked patients to report any thigh or groin pain to their doctors. At the same time, the F.D.A. safety announcement emphasized that people should continue taking the drugs unless their doctors advise otherwise.
The F.D.A. notice came amid an ongoing agency review of the safety and effectiveness of the biphosphanate drugs to treat or prevent osteoporosis. The drugs have been heavily marketed to women and the market has grown since 1995 into an estimated $8 billion worldwide.
Biphosphanates, which slow the loss of bone mass, have been proven to reduce the risk of hip or spine fractures in older women. But they have also attracted nagging safety concerns, which previously focused on jaw osteonecrosis, arrhythmias and esophageal cancer.
The rare bone breaks are known as subtrochanteric femur fractures, just below the hip joint, and diaphyseal femur fractures, in the long part of the thigh.
The F.D.A. said the labels and medication guides will be changed to show the new warning in oral bisphosphonates including Actonel, Atelvia, Boniva, and Fosamax and injectible drugs including Boniva and Reclast, and their generic equivalents.
Genentech is working closely with the F.D.A. to add a statement to Boniva labels warning of the possible increased fracture risk, according to Terry Hurley, spokesman for Genentech, the Roche
subsidiary which sells Boniva in the United States.
“While no causal link has been established, we believe it is the right thing to do for patients,” Mr. Hurley said Wednesday. He added,“Boniva has been studied extensively in clinical trials and more than
20 million patients have been treated worldwide since the monthly medicine was approved in 2005.”
A review in the New England Journal of Medicine in March reported that the cause of the fractures was unknown, and that the benefits of the drugs far outweighed the risk.
But last month, the American Society for Bone and Mineral Research recommended the government issue a warning about the thigh bone fractures after a study of 310 of them found that 90 percent had taken biphosphanates.
The F.D.A. on Wednesday said it has not been proven that the biphosphanates cause the unusual fractures, but they have shown up in disproportionate levels among patients taking the drugs, especially those who take them for more than five years.
In a statement, Dr. Theresa Kehoe, an F.D.A. osteoporosis expert, said the agency is continuing to evaluate the safety and effectiveness of biphosphanates when used for long periods.
An earlier version of this post omitted a word in a description of a review in the New England Journal of Medicine. It should have said the review reported that the cause of the fractures was unknown and that the benefits of the drugs far outweighed the risk.
Here's Your Healthy Tip of the Day: Don't be stupid or lazy. Read the fine print on all medications before taking them and if you have questions, do not hesitate to contact your healthcare professional. YOU and ONLY YOU are responsible for swallowing medications and it is YOUR RESPONSIBILITY to be an educated consumer!!!
Thursday, October 14, 2010
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