FDA reviewing osteoporosis drugs Fosamax, Boniva, Actonel for safety
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.
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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
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 - 6:47amDr. 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 - 9:33amHi 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 - 8:12pmHello,
March 18, 2010 - 7:21pmI have been taking boniva for 4 months and am currently recovering a stress fracture in the femoral head. I have just heard about the bisphosphonate interactiions over an extended period of time. What do you think of this short period of time. I was not in an accident.
Stress fractures in the femoral head are fairly unusual in adults and in my opinion, suspicious of a bisphosphonate induced injury.
March 21, 2010 - 7:23amYou would think the best and brightest research scientists at Merck just might have asked themselves what thelong term effect of shutting of the process of natural bone metabolism & regeneration might do over time. It would be like a plumber advising you to fix a leaky septic tank by filling it with cement. It would work for awhile until the you know what backs up.
March 25, 2010 - 2:48pm"That's the paradox," Melvin Rosenwasser, chief of orthopedic trauma surgery at Columbia University Medical Center in New York, told USA Today.
I'm not sure why this is such a paradox to the chief of ortho trauma. Its a simple inventory issue. Think of a women's bones as an inventory supply of bone cells moving in and out of the "warehouse" (bones)
These women present with more old bone cell going out than they have new bone cell coming in.....so they take Fosamax and "freeze the inventory". Then it seems like its working great for a good five-ten years before all of the "inventory" is way beyond its fresh date and essentially worthless.
Why is anyone in the medical community surprised? Paradox my foot. It is the simple, predictable outcome of the basic mechanism of the drug. All this talk about how much good the drug does is just so much vacant thinking and flumdiddle. If I stop paying my mortgage, its great for a while, then it gets worse, then they take my house away.
Now that Iknow the mechanism of action of these drugs, l wonder what kind of moron at the FDA wouldn't ask the question "what happens went the rent comes due on that mechanism of action?"
March 25, 2010 - 7:57pmOh it is the drugs. Given their mechanism of action, they did exactly what they could have been expected to do. They changed the bone metabolism process, which stopped the resorption of bone cells. In the short run this gave patients more bone mass. But in the long run it gave them dead bone cells. Women were left with bones like dead branches on a tree. Eventually, the truth will show that this was suspected and reasonably predictable from the very start.
If they depose enough drug reps and doctors, they will find that terms like "drug holiday" and "Fosamax holiday" were being promoted and talked about from the very beginning, which tends to show that there were questions or uncertainty about the effects of long term suppression of the natural bone metabolism and formation process. They should have had FORMAL protocols for therapt time frames from the start and they should have given SERIOUS notice to doctors to consider discontinuing therapy to women who had been taking this drug for longer than "X" number of years.
Having your sales force address doctor's concerns of the obvious long term risk of the drug's mechanism by casually promoting "bone holidays" shows prior knowledge and recklessness. If the risk of not taking "bone holidays" is spontaneously exploding femurs, then that treatment protocol should have been developed, addressed and formalized before the drug even came out and gained FDA approval.
Once again, sales and marketing was used to tap dance around a serious scientific question and a safety risk that was reasonably predictable.
March 27, 2010 - 9:22amHi:
I am a 58-year-old female who had been taking Fosamax and/or Fosamax D since 1997 at the urging of my dr after my bone density test indicated bone less in my right hip. I had no issues with it but grew tired and weary of the weekly ritual and reading about all the lawsuits, although my dentist did tell me that I would encounter problems upon any tooth extraction. I did not ask and did not want to know at the time. I recentlly had a bone density test which indicated I now have Osteopenia and have bone thinning in my spine. I asked the doctor if it would be a good idea to switch to Boniva and he said yes. Well, that was three months ago. Since I started taking Boniva, I have developed joint and muscle pains all over my body -- arms, legs and back. I don't understand and am ready to quit all meds as I feel like a guinea pig. I am 5'3, 112 lbs., exercise and in good health otherwise. I told you what I thought; please tell me what you think!
April 12, 2010 - 10:20am