Keep the story alive by sharing your experiences.
"My mother is 76 years old and was taking Fosamax and Boniva for over 8 years. She too fractured her femur just walking down 2 steps it happened out of nowhere. She had a rod put in because the fracture never healed itself and the Dr. warned her it could break at any moment as well as the other side. She suffered a lot of pain and was in the hospital for 1 week, rehab nursing care for 3 weeks, at home rehab for 2 months now and still walking with a walker in fear of falling at any moment if the other side fractures. She has pain every day and the Dr. told her it was all from the two drugs she was taking. Its a damn shame what this drug has done to my mom it has destroyed her life. She will never be the same active woman she once was."
This is one of hundreds of stories shared on the “comments” pages of ABC News. Last week ABC’s Dr. Richard Besser did a piece on the tendency of the osteoporosis drug Fosamax to cause broken femurs (thigh bones) in long-term users. (Fosamax: Is Long-term Use of Bone Strengthening Drug Linked to Fractures?)
I’m not sure Besser knew what he was getting into. At the end of the piece, viewers were invited to share their experiences on the ABC website, and over the next week share they did, by the hundreds. I have to admit that my eyes were brimming as I read story after story after story from women whose femurs suddenly snapped without warning.
The femur is the strongest bone in the body, and most of these women were doing low impact, low energy activity, like walking across a room. All describe unbearable pain and a long, uncertain recovery. All were long-term users of the bisphosphonate osteoporosis drugs, a category which includes Fosamax, Actonel, Boniva and Reclast.
Did the FDA Know about Fosamax and Fractured Femurs?
When Besser called the FDA they declined an interview and said they’d look into it. On day two an FDA bureaucrat talked to Besser via Skype to say, “The FDA is not aware of any connection between bisphosphonates and fractures of the femur but we’re looking into it.” By day three the FDA had released a statement that doctors should “Be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.”The FDA most certainly knows perfectly well about the connection between bisphosphonates and fractured femurs, and has for many years. In 2008 they asked Merck, the maker of Fosamax, to look into the connection, and a year later the drug company declared there was no connection. Well, what did the FDA expect Merck to say?
Decay and Denial, Brought to You by Merck
According to Merck, “A causal relationship between Fosamax and these fractures has not been established.” I got yer causal relationship right here: According to a report from IMS Health, in 2008 bisphosphonate sales exceeded $3.5 billion. I won’t even bore you with the twisted logic Merck and other bisphosphonate makers used to deny the causal relationship—a fifth grader could have figured out it was a bunch of hooey.Merck is famously (or infamously) the manufacturer of Vioxx, the pain drug withdrawn from the market in 2004 because it significantly increased the risk of heart attack. It’s estimated that Vioxx-related lawsuits could ultimately cost Merck as much as $30 billion. The lawsuits have been filed because Merck clearly knew about the heart attack risk long before it pulled the drug.
And lest we forget, Merck is responsible for HPV vaccine, Gardasil. See my story, Truthiness in Advertising - Gardasil - Risks, Dangers, Side Effects. Reports continue to stream into various anti-Gardasil websites about girls becoming very sick or dying after getting the Gardasil vaccine. The FDA continues to “look the other way,” oops I mean “look into it.”
What Exactly is the “Right Group” of Women?
But back to Fosamax—Besser keeps saying, day after day that, “…these drugs prevent a lot of hip fractures when given to the right group of women,” and that women should make sure they are “part of the group that needs to take them.” OK Dr. Besser, you are a doctor, what exactly defines the “right group” of women?Why ABC keeps claiming that Besser “broke the story” on Fosamax and femur fractures is a mystery. Dr. John Lee warned about it in a 1998 issue of his Medical Letter in an article titled, “Throw Away Your Fosamax” which said in part:
Like its close relative etidronate (Didronel), the osteoporosis drug alendronate(Fosamax) is of very questionable value and has potentially harmful side effects. Fosamax is billed as the only non-hormonal drug approved to treat osteoporosis, but studies of this drug were cleverly stopped at four to six years. This is just the point at which the fracture rate for women taking similar drugs such as Didronel began to rise.
The problem is that these types of drugs temporarily create denser-looking bones in bone density tests because they block the resorption of old bone. But old bone is constantly resorbed and replaced because it's weak and needs to be replaced, and it can't be replaced if it isn’t resorbed. In people who take Fosamax, the old bone remains in place and over time begins to crumble, and eventually this is likely to cause the fracture rate to sharply increase.
Dr. Susan Ott of the University of Washington in Seattle has been warning us about the dangers of bisphosphonates for years. In a 2004 article in the Annals of Internal Medicine she wrote, “In fact, bone biopsy studies from patients treated with risedronate [Actonel] or alendronate [Fosamax] show that mineralizing surface, which is forming bone, decreases 80% to 96% after 3 years of treatment. The bone volume however, does not significantly change.” In other words, these drugs prevented new bone growth and did not increase bone density.
A 2005 study in the Journal of Clinical Endocrinology & Metabolism concluded: “Our findings raise the possibility that severe suppression of bone turnover may develop during long-term alendronate therapy, resulting in increased susceptibility to, and delayed healing of, nonspinal fractures. …Our observations emphasize the need for increased awareness and monitoring for the potential development of excessive suppression of bone turnover during long-term alendronate therapy.”
A 2007 review article in the Journal of Bone and Joint Surgery concluded: “Our study suggests that prolonged suppression of bone remodelling with alendronate may be associated with a new form of insufficiency fracture of the femur. We believe that this finding is important and indicates the need for caution in the long-term use of alendronate in the treatment of osteoporosis.”
A 2008 study published in the Journal of Orthopaedic Trauma concluded: “Low-energy fractures of the femoral shaft with a simple, transverse pattern and hypertrophy of the diaphyseal cortex are associated with alendronate use. This may result from propagation of a stress fracture whose repair is retarded by diminished osteoclast activity and impaired microdamage repair resulting from its prolonged use.”
Keep this Story Alive
If you or someone you know suffered a fractured femur after use of Fosamax, please share it in the comments section of one of the ABC stories (links below), and report it to the FDA. Let’s keep the evidence rolling in until the FDA can no longer look the other way.Osteoporosis Drugs, Like Fosamax May Increase Risk of Broken Bones in Some Women
Fosamax: Is Long-term Use of Bone Strengthening Drug Linked to Fractures?
FDA to Investigate Possible Osteoporosis Drug-Femur Fracture Link After ABC News ReportIf you’d like details about how and why Fosamax and other bisphosphonates cause the femur to fracture, please read Lane Lenard’s Health Watchers’ News and Views article, Bisphosphonates: Bone Strengtheners or Bone Hardeners?
For insights on the politics of osteoporosis diagnoses and drugs, see the articles on my Osteoporosis links page, and for detailed, excellent advice on how to maintain strong bones, read the chapter on osteoporosis in What Your Dr. May Not Tell You about Menopause.