FDA Reviewing Fosamax, Other Bone Drugs For Link to Femur Fractures
Date Published: Thursday, March 11th, 2010
Oral bisphosphonate medications, a class of drugs that includes Fosamax, Actonel, Boniva, and Reclast, are undergoing a Food & Drug Administration (FDA) safety review because of a possible association with femur fractures.
Oral bisphosphonates are used to prevent and treat osteoporosis in post-menopausal women. The drugs work by partially blocking the body’s natural process involved in removing and rebuilding bone tissue. However, there are concerns that drugs like Fosamax could cause brittle bones over the long term that are more susceptible to fractures.
The FDA review was prompted by media reports linking Fosamax and the other drugs to atypical subtrochanteric femur fractures in some patients who’ve been on the drugs for several years. Such fractures occur in the bone just below the hip joint and can be extremely painful.
According to a report in The Wall Street Journal, two studies presented this week at the American Academy of Orthopaedic Surgeons’ annual meeting suggest the drugs might adversely affect bone quality and increase risk of atypical fractures of the femur when used for four or more years. One study by researchers at Columbia University compared the bone structure of 61 postmenopausal women with osteoporosis who had been taking bisphosphonates for a minimum of four year to 50 similar patients taking calcium and vitamin D supplements. While patients using bisphosphonates did experience improvement early on, the researchers found that “after four years of use, these trends reversed, revealing an association between prolonged therapy and declining cortical bone structural integrity.”
The second study, conducted by researchers at the Hospital for Special Surgery in New York, looked at bone samples taken from 21 post-menopausal women who were treated for femoral fractures. Of these, 12 patients had a history of bisphosphonate treatment for an average of 8.5 years, while nine women hadn’t been treated with the drugs. According to The Wall Street Journal, the study found that the subjects taking bisphosphonates had a reduction in bone tissue heterogeneity compared with women not receiving the drugs, which suggests there might have been a difference in bone quality parameters.
According to a notice posted on the FDA’s Web site, in June 2008 the agency requested information from all bisphosphonate drug manufacturers regarding the potential for atypical femur fractures. According to the FDA, a review of available data did not show an increase in this risk in women using these medications.
In announcing this safety review, the FDA said it would work closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.
The FDA has advised that healthcare professionals continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications, the agency said.
This entry was posted
on Thursday, March 11th, 2010 at 7:56 am and is filed under Pharmaceuticals.
Oral bisphosphonate medications, a class of drugs that includes Fosamax, Actonel, Boniva, and Reclast, are undergoing a Food & Drug Administration (FDA) safety review because of a possible association with femur fractures.
Oral bisphosphonates are used to prevent and treat osteoporosis in post-menopausal women. The drugs work by partially blocking the body’s natural process involved in removing and rebuilding bone tissue. However, there are concerns that drugs like Fosamax could cause brittle bones over the long term that are more susceptible to fractures.
The FDA review was prompted by media reports linking Fosamax and the other drugs to atypical subtrochanteric femur fractures in some patients who’ve been on the drugs for several years. Such fractures occur in the bone just below the hip joint and can be extremely painful.
According to a report in The Wall Street Journal, two studies presented this week at the American Academy of Orthopaedic Surgeons’ annual meeting suggest the drugs might adversely affect bone quality and increase risk of atypical fractures of the femur when used for four or more years. One study by researchers at Columbia University compared the bone structure of 61 postmenopausal women with osteoporosis who had been taking bisphosphonates for a minimum of four year to 50 similar patients taking calcium and vitamin D supplements. While patients using bisphosphonates did experience improvement early on, the researchers found that “after four years of use, these trends reversed, revealing an association between prolonged therapy and declining cortical bone structural integrity.”
The second study, conducted by researchers at the Hospital for Special Surgery in New York, looked at bone samples taken from 21 post-menopausal women who were treated for femoral fractures. Of these, 12 patients had a history of bisphosphonate treatment for an average of 8.5 years, while nine women hadn’t been treated with the drugs. According to The Wall Street Journal, the study found that the subjects taking bisphosphonates had a reduction in bone tissue heterogeneity compared with women not receiving the drugs, which suggests there might have been a difference in bone quality parameters.
According to a notice posted on the FDA’s Web site, in June 2008 the agency requested information from all bisphosphonate drug manufacturers regarding the potential for atypical femur fractures. According to the FDA, a review of available data did not show an increase in this risk in women using these medications.
In announcing this safety review, the FDA said it would work closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.
The FDA has advised that healthcare professionals continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications, the agency said.
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This entry was posted
on Thursday, March 11th, 2010 at 7:56 am and is filed under Pharmaceuticals.
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March 11th, 2010 at 7:46 pm
Keep taking the drug even after proof it is breaking bones? What has happened to the FDA? Let me guess. A former pharmaceutical lobbyist is head of the FDA.
March 12th, 2010 at 5:58 am
I hae been on Fosmax and its generic for 15 years. I have been dealing with a stress fracture in my foot that will not heal since Sept 1, 2009. Could there be a connection?
Debby Crawford
March 23rd, 2010 at 4:29 am
The 2010 AAOS meeting presented studies from the Hospital for Special Surgery (HSS) and Columbia University Medical Center showing that Fosamax disturbs bone formation, and implicated Fosamax in spontaneous mid-femur fractures (without trauma).
Clarita Odvina MD reported nine cases of spontaneous femur fracture on Fosamax. Dr. Goh, a doctor in Singapore, identified nine more cases in his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term Fosamax. Joseph M Lane MD reported 15 cases of spontaneous femur fracture in women on Fosamax with a unique radiographic pattern. How many more case reports do we need?
Perhaps we should re-evaluate a drug that causes spontaneous mid femur fractures, jaw necrosis, and diffuse bone and joint pain. The FIT study, published in JAMA in 1998, was a double blind placebo controlled study which failed to reveal these adverse side effects, indicating a flawed drug approval process. The bone histology slides show these drugs disturb bone physiology, creating pathological and weakened bone. The bone histology slides don’t lie.
jeffrey dach md