Improved
6112 HealthChanged
3785 LivesSaved
3568 Lives0 lives impacted in the last 24 hrs Learn More
At EmpowHer, we have a thread where women have reported femur fractures while using the drug Fosamax, a medicine meant to help build bones for those suffering from osteoporosis. It turns out these women aren't alone.
There have even been a couple of research studies showing the link.
On Wednesday, the Food and Drug Administration said it is doing a safety review of the drugs known as bisphosphonates, which include Fosamax, Boniva and Actonel, specifically to see if there’s a risk of fractures to the femur just below the hip joint in patients who have taken the drugs for several years. However, the agency says that the information they have so far reviewed has not shown a clear connection between the drugs and the fractures. From the Wall Street Journal:
“Two studies presented Wednesday 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, or the main bone in the thigh, when used for four or more years.
“The FDA said it had requested information from drug manufacturers in 2008 after seeing case reports about femur fractures occurring in women with osteoporosis using bisphosphonates.
"FDA's review of these data did not show an increase in this risk in women using
these medications," the agency said in a statement posted to its Web site Wednesday. The agency also cited a 2008 study that found similar femur fracture rates among women taking bisphosphonates compared to women not taking the drugs. The study found that the femur fractures had many features in common with osteoporotic hip fractures.”
What does that mean? Simply put, the FDA can’t be sure whether the fractures have to do with the osteoporosis or the medicines meant to prevent it.
There does seem to be a correlation between the length of time patients have taken the drugs and the increased risk. The studies showed that the bones of some women stop rejuvenating after five or so years on the drug and become brittle.
"That's the paradox," Melvin Rosenwasser, chief of orthopedic trauma surgery at Columbia University Medical Center in New York, told USA Today. "These drugs are good drugs. They strengthen bone and protect you from fractures for a while. But in some people they can become deleterious after a period of time." More from that report:
“The drugs are effective initially in slowing bone loss, says Joseph Lane, chief of metabolic bone disease service at the Hospital for Special Surgery in New York. Research he will present today at the annual conference of American Academy of Orthopedic Surgeons in New Orleans was designed to explore why one in 50 women who got fractures and were on the drugs for more than five years suffered atypical hip fractures of the femur.
"These are healthy active women, not women in nursing homes," Lane says. "Hip fractures can be life-threatening, so we want to find out what's causing them in thriving women."
“Studying bone biopsies in women who suffered femur fractures, Lane found the quality of the bone diminished after long-term bisphosphonate use.
"Normally bone is a distribution of young bone, middle-age bone and old bone," he says. "When we look at these bones, it's old bone. You begin to start having imperfections in the bone. It's not as good as younger bone."
An estimated 10 million Americans have osteoporosis, and 34 million have low bone mass, putting them at risk. The National Osteoporosis Foundation has a page on its website titled “Special Concerns About Biophosphates,” good reading for anyone concerned about these and previous studies.
Here’s a link to that page:
http://www.nof.org/news/pressreleases/F-1_Special_Concerns_About_Bisphos_2009.pdf
And here’s the original EmpowHer thread:
https://www.empowher.com/community/share/fosamax-and-femur-fractures
The Wall Street Journal story:
http://online.wsj.com/article/SB10001424052748703976804575114181349999398.html
The USA Today story:
http://www.usatoday.com/news/health/2010-03-11-bones11_st_N.htm
Add a Comment14 Comments
Hi Diane,
This is a difficult question for patients who have been on bisphosphonate osteoporosis drugs for years and then abruptly find out that there are serious adverse effects such as spontaneous mid femur fracture. What recourse do these patients have at this stage? We know that these drugs stay in the bones for a long long time, and there is no way to remove the bisphosphonate chemicals from the bone matrix. So I dont have an answer, and there may not be an answer. What question to ask the osteoporosis doctor? Try asking, "Why did you give me a "bad drug" with adverse side effects, and why didn't you try natural treatments instead ?"
jeffrey dach md
March 16, 2010 - 8:12pmThis Comment
The Fosamax (Alendronate) study done for FDA approval failed to show any benefit for the majority of the worried well, which is the osteopenia group defined as T score greater than -2.5. This Osteopenia Group actually had higher fracture rates than placebo. This was published by Cummings in JAMA in 1998.
Bisphosphonate drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous mid-femur fracture, heart rhythm disturbances, and severe bone and joint pain.
The spontaneous mid femur fractures are especially troubling, since these are spontaneous fractures without any trauma. Subtrochanteric fractures are pathological fractures, indicating the underlying bone matrix is abnormal. This anormal weakening and brittleness is directly caused by the bisphosphonate drug.
Bottom Line: These are BAD drugs that actually make the bones weaker not stronger, and they should be banned by the FDA . However, knowing the FDA which is in the pocket of the drug companies, no action will be taken until many more women victims suffer from these drugs, and many more cases work their way through drug litigation court..
http://www.drdach.com/Fosamax.html
jeffrey dach md
March 15, 2010 - 6:47amThis Comment
Dr. Dach,
I see from your online bio that you are board certified in Diagnostic and Interventional Radiology. Clearly you have experience with these kinds of patients and this category of drugs.
What questions do you suggest women ask their doctors if they have been on any of these drugs? The doctor-patient relationship can be difficult when a patient is questioning a doctor's advice, especially when it's something she read online.
March 16, 2010 - 9:33amThis Comment
The investigation into this link should include whether or not any of these women had also had a hysterecotomy. A recently published article by Dr. William Parker revealed an increase in cardiovascular disease and bone loss in women who had a total hysterectomy. If there is a connection, this should raise further mandate against the needless hysterectomy; the number 1 surgical procedure for women!
March 11, 2010 - 9:17amThis Comment