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FDA reviewing osteoporosis drugs Fosamax, Boniva, Actonel for safety

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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.

Add a Comment14 Comments

EmpowHER Guest

more conflicting information on bisphosphonates..
i am 65 and have osteopenia..very close to osteoporosis in numbers,
and one section does come up osteoporotic
have been told by dr joseph lane...that an infusion of reclast
should be done...
read all of these comments partic. by dr dach..and worry a lot
about doing this...should i..should i not...and there must be
many more of "me" out there....

January 30, 2011 - 12:17am
EmpowHER Guest

Add me to the list of women who have suffered femur stress fractures. I am a healthy 63 yr. old woman...no issues other than taking boniva for 10 yrs. at the suggestion of my gynecologist for osteopenia. I am recovering now from surgery...a rod placed in my right femur because of stress fractures. It is a difficult recovery and I will start rehab soon to learn to reuse the leg. I face possible surgery in the left femur which also has hairline fractures. I believe this is due to boniva and hope that the FDA will investigate and will issue warnings and take steps to be sure that physicians know about this issue. I think we are the tip of an iceberg and more women will suffer needlessly. Thank you. Karen Amdur

October 4, 2010 - 4:59pm
EmpowHER Guest

Just letting you know that I have been on bisphosphonates nearly 20 years now (I live in NZ and am a 63 year old male). Unfortunately there seem to be NO long term studies on people like me who have been using these drugs (in oral and intravenous forms) for many many years. Having said that, I have not had any fractures since 1992 0 I have 3 vertebral fractures, I am still active in cycling and jogging - but no more skiing. I have had two serious falls in the last decade w/o any more fractures - a surprise to both myself and my health care professionals. And my bone density has actually increased, especially in the last decade, to where I am now only about a standard deviation below normal as compared to three and a half standard deviations below normal for my age since 1990 when my first fractures occurred.

It is too simplistic to attribute these reasonably good clinical outcomes to the drugs, especially when there are so very few comparators. But thats the way with many complex conditions and complex drugs. Lifestyle has to make a difference, since my brother, who also had osteoporosis died several years ago - even though on fosoamx every vertebrae in his spine had collapsed (he also had schizophrenia for many years which kept him depressed and inactive - ). A key thing here is NOT to get worried by the fact that some people either dont tolerate or dont respond to some drug well, or or whom the drug may actually worsen things. There is sooooo much individual variation in how each of us process all kinds of foods drugs etc that we are stuck in the fog of averages - until the genetic marker come out that can indicate who can take what - and not take waht - safely. Life is a gamble, health and health states are gambles, and the gambles change with treamtnet - non treatment - choices. Choose your gambles wisley.


May 3, 2010 - 6:53pm
EmpowHER Guest


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
Expert HERWriter Guide Blogger (reply to Anonymous)

Anon - Thanks for writing, and welcome to EmpowHER.
For those who aren't familiar with Osteopenia, this is mild thinning of the bones, but not as severe as osteoporosis. Osteopenia results when the formation of bone is not enough to offset normal bone loss. Osteopenia is generally considered the first step along the road to osteoporosis, a serious condition in which bone density is extremely low and bones are porous and prone to shatter. Diminished bone calcification, as seen on plain X-ray film, is referred to as osteopenia, whether or not osteoporosis is present. The diagnosis of osteopenia may also be made through bone density testing. The World Health Organization defines osteopenia as a bone density between one standard deviation (SD) and 2.5 SD below the bone density of a normal young adult. Osteoporosis is defined as 2.5 SD or more below that reference point.

We've heard from others about their thoughts and experiences with medications, and we also have information on Osteopenia which you may find helpful.


Let us know if we can answer questions or provide additional information.
Take care, Pat

April 12, 2010 - 5:28pm

Oh 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 - 9:22am

"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 - 7:57pm

You 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

Stress fractures in the femoral head are fairly unusual in adults and in my opinion, suspicious of a bisphosphonate induced injury.

March 21, 2010 - 7:23am
EmpowHER Guest

I 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.

March 18, 2010 - 7:21pm
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.


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