Prescriptions: F.D.A. Warning on Bone Drugs

[Guest guest]

Well, it's good to see that the FDA is finding out that this pharmaceutical is bad. Thankfully, Dr. Mercola and others, have already warned us. I wonder if Sally Field has heard.

http://www.aarp.org/health/drugs-supplements/news-10-2010/prescriptions_f_d_a_warning_on_bone_drugs.html?cmp=NLC-RSS-DAILY-BULLETIN

Prescriptions: F.D.A. Warning on Bone Drugs

by: DUFF WILSON | from: New York Times | October 14, 2010

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.A review in the New England Journal of Medicine in March reported the cause of the fractures was unknown and far outweighed by the benefits of the drugs.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 far outweighed by the benefits of the drugs.

This article "Prescriptions: F.D.A. Warning on Bone Drugs" originally appeared at the New York Times.