Fosamax and femur fractures : FDA is investigating possible links

Tuesday, March 9th, 2010 By

An x-rayed femur

The femur is one of the strongest bones in the body. Image from Flickr.

A connection between Fosamax and femur fractures is currently under investigation by the FDA. Fosamax is a drug intended to treat bone weakness, though some doctors have been noticing a possible connection to Fosamax and fractured bones. The Medicine and Healthcare Regulatory Agency out of the UK published information in March of 2009 about the “atypical stress fractures” in patients taking Bisphosphonates such as Fosamax.

What is Fosamax?

Fosamax is a drug intended to treat osteoporosis – the weakening of bones that happens due to age or lack of certain nutrients. These drugs work kind of like short term installment loans – they shut down the cells that cannibalize bone tissue, which strengthens the bone. It’s a member of the class of drugs called “bisphosphonates.”

How are Fosamax and femur fractures connected?

However, just like an installment loan, this bone has to eventually be paid back to the body. Dr. Robert Bunning, a rheumatologist at National Rehabilitation Hospital in Washington DC theorizes that extended use of these drugs (over 5 years) lead to “frozen bone” syndrome, where the bones are so dense they become very brittle.

What is the FDA doing about the connection between Fosamax and femur fractures?

The FDA has stated that it is “aware of and investigating” the connection between taking Fosamax and femur fractures. It has not yet presented any study results or required a warning to patients and doctors. In the past, though, the FDA has put out safety reviews of the bisphosphonate drug class that include warnings about severe bone and joint pain that can be caused by these drugs.

What if I take Fosamax?

If you currently take Fosamax or any other bisphosphonate drug, you should first and foremost talk to your doctor. Osteoporosis, the condition Fosamax is intended to treat, can be very dangerous if left untreated. The FDA and the company that makes Fosamax have yet to come out with any definitive studies on connections between Fosamax and femur fractures, so you should make a decision based your opinion and that of your doctor.

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This post has 23 comments

  1. Cecelia Tkach says:

    Now lets discuss Gardasil, Merck's mandatory vaccine for kids from 9 to 15 who could contract an STD. However, whether they are sexually active or not, it is mandatory that they receive this vaccine. Who is the proud owner of this vaccine, Merck. Who helped Merck make it mandatory for young children (male and female), the FDA.

  2. Guest says:

    Is there any test you can take to see if you are one of the people who might get this fracture before actually getting it?

  3. gues says:

    Only the medical profession could justify the breaking of a bone by saying it is better than breaking the other bone. How dysfuntional..

  4. susan macklin says:

    I am takeing the generic brand of fosamax and have been for about 3-4 years.I was diagnosed with osteopinia and am very reluctant to take this medication due to all the reports of the *dead jaw* which i have had tmj for years in the jaw and have hurting hips and bad knees,so i am thinking about talking to my doctor about this serious business of fosamax and the effects it can have on a person.hopefully they will come up with a deffinite answer to all these questions..

  5. Amy Thompson says:

    March 29, 2010, I tripped over a box, fell and broke my femur. I had a 12 in rod put in my leg and was in a nursing home for therapy for 2 months. I'm still using a walker and crutches to get around. I have been on Fosomax several years for osteoporosis. I was at Mayao Clinic in Rochester, MN this week and that's when I found out about the Fosomax/femur fracture connection. My Dr. took me off Fosomax. I have intense pain almost every night. What more can I expect? How long has it taken others to recover fully?

  6. mia Betenat says:

    Women should have both DXA bones scans and FRAX questionnaires to determine whether they need this class of drugs. Very few women get these atypical subtrochanteric femur fractures, which doesn't help if you're one of them.In a recent study, more than one-third the women who did have these fractures were taking a bisphosphonate (but that also means two-thirds were not). It's a question of weighing the risks. It appears the most likely femur-fracture victims are younger, more active and the medication for a long time. Some seem to be on other drugs as well. (June 2010 issue of More magazine has an excellent article on this.) Some doctors are recommending alternative medications if a patient is in her fifties than if she is in her eighties. More says "One scenario might involve a patient taking a low dose of estrogen close to menopause to protect bones and help with menopausal sumptoms, followed by Evista to reduce the risk of breat cancer and oseoporosis, and then use bisphosphonates if needed later in life when hip-fracture preventuion becomes increasingly important." That takes both an active patient and an active doctor who do research, are willing to investigate alternatives, and keep tabs on their health. There's no doubt that bisphosphanates are viable in preventing hip fractures for a certain population. Preventing that population from obtaining them is tentamount to refusing a vaccine to the population who needs it because a small population suffers from severe side effects. As a woman in her fifties whose doctor prescribed Fosomax, I'm taking myself off it (with the approval of my doctor) after 4 years. I am genetically predisposed to osteo but I am too young to take this drug, based on all the research I have to date. Individuals need to be proactive about researching their own situation and work with a doctor who is open minded and up on modern study results.

    • guest says:

      Does anyone know how long it takes to get fosamax out of the body and bones after one stops taking it so the risk for this unusual fracture goes back to normal?

      I am concerned about spending the rest of my life carrying a cell phone around in case I stand up wrong and get a rare fracture from taking foxamax and then stopping.

  7. Annette DeBoer says:

    Fosamax has destroyed my life as I knew it. Last year in July I experienced a non-thrumatic bone fracture which made it impossible to walk without pain,but it was misdiagnosed at that time. Then the nest November I collapsed in my doorway and came down on my femur bone which was over the door sill and had a bad break, nonunion and comminuted. It was fixed with a rod and screws. Now it is June and I am still unable to walk with out a crutch. The suffering was terrible, and the expense. I know I am a classic example of what Fosamax can do. I had been on it for several years. Now what do I do???

  8. Patricia O'Dea says:

    Hello–

    I have been on Fosamax for probably 6 or 7 years. I have osteoporosis and R.A. I am on methotrexate and a low dose of prednisone for my R.A. After hearing the report on fractures due to Fosamax, I went to my general doctor who said to stop taking it. I also consulted my rheumatologist, who said I should stay on it due to my osteoporosis. Whom am I to believe?? I am totally confused and have been off of it for a month, but I am torn in my decision.

    I fell a year ago and fractured both bones in my arm, requiring two surgeries to put in a new radial head and a plate to secure the bones. So, I know I am susceptible to fractures. I am so careful now, walking very trepidly, wanting to avoid any more mishaps. I hope someone finally clarifies this issue!

  9. Jeffrey Dach MD says:

    The 2010 AAOS meeting which presented studies from the Hospital for Special Surgery (HSS) and Columbia University Medical Center which showed 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.

    Perhaps we should re-evaluate a drug that causes spontaneous mid femur fractures, jaw necrosis, and diffuse bone and joint pain. You don't need a double blind placebo controlled study to show a drug disturbs bone physiology. The bone histology slides don't lie.

    jeffrey dach md

  10. Linda Blackburn says:

    My 95 yr old Mother just broke her femur just below the hip. She has been on Fosamax for years. She had to go through a very difficult surgery & probably endless rehab. They put a long rod & screws & is living on strong pain mecication. She had a light fall on the carpet which should not have caused such a break. A week prior to this fall, she had been at her sewing machine & had made 24 hot pads for gifts. Now all she can do is lay in a bed & sometimes sit up to eat.

  11. Jeffrey Dach MD says:

    Dear Dr Lynch,

    Perhaps you should also be calling insanely irresponsible the 2010 AAOS meeting which presented studies from the Hospital for Special Surgery (HSS) and Columbia University Medical Center which showed that Fosamax disturbs bone formation, and implicated Fosamax in spontaneous mid-femur fractures (without trauma).

    Perhaps you should also be calling reckless, biased and irresponsible Clarita Odvina MD who reported nine cases of spontaneous femur fracture on Fosamax. Or Dr. Goh, a doctor in Singapore, who identified nine more cases in his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term Fosamax. Or Joseph M Lane MD who reported 15 cases of spontaneous femur fracture in women on Fosamax with a unique radiographic pattern.

    Rather, I would say it is insanely irresponsilbe to give women a drug that causes spontaneous mid femur fractures, jaw necrosis, and diffuse bone and joint pain.

    You don't need a double blind placebo controlled study to show a drug disturbs bone physiology. The histology slides don't lie.

    Conflict of interest? That is a laugh. Drug companies clean up on Fosamax,a 3 billion dollar industry. Now that kind of money can generate a real conflict of interest, documented by Aubrey Blumsohn MD who blew the whistle on the Actonel studies.

    jeffrey dach md

  12. Bonnie Hay says:

    3/22/2010 Real life incidents do count! 10 years ago (I was 48) I had a spontaneous hip fracture (while being treated for what doctors thought was a back problem). After surgery I was put on Fosamax and have been on it for the past 10 years. 3 years ago I was walking out to my car and again experienced a spontaneous mid thigh displaced femur fracture. I had been experiencing months of pain in my hip and thigh and the doctors felt the hardwear from my previous surgery needed to come out. Unfortunately before that could happen my femur broke (8 hours in surgery). I continue to have a great deal of pain on my right side along with the fear of this happening again – I will be very interested in the final findings.

  13. Jorge Anglin says:

    I am truly appalled it is absurd that nothing has been done about this drug that has been allegedly linked to casusing femur fractures. My mother just had an operation on her hip and she sustained an femur fracture and she was taking fosamx prior to the surgery had I had known she would possibly had been at risk of having her femur fractured the surgery would have most likely not have taken place. Please send me more information regarding this potentially dangerous medication

  14. Terri Lewis says:

    I am going through the same hell. My femur broke spontaneously while standing on a sidewalk in Spain on June 6, 2008. It was a complete shearing of the leg. I am still on a cane and still in therapy nearly two years later. I was on Fosamax for 11 years prior to the break–and just as a preventive measure since my bone densities were low normal. Now FDA has investigated and has concluded that there is no firm evidence supporting the association between bisphosphomates and femur fractures. I don’t believe it!!

  15. Jeffrey Dach MD says:

    Fosamax, A Drug in Litigation, Under FDA Review

    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 data was data published by Cummings in JAMA in 1998 Fracture Intervention Trial.

    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..

    • S.Lynch MD says:

      Dear Dr. Dach:

      What an INSANELY IRRESPONSIBLE thing for you to say. You have NO SCIENCE to back up such a statement. The reality is that bisphosphonates are WELL PROVEN with double blinded, randomly controlled studies to REDUCE FRACTURES in those at the most risk. If there appears to be a link here, then it should be thoroughly investigated with SCIENCE, as opposed to blanket statements by "doctors" with CLEAR CONFLICT OF INTEREST. Maybe there is a role for a drug holiday, maybe there are predisposing factors in these particular individuals such as drug-drug interactions. To impugn an entire class of medications with undeniable benefit to humanity: YOU ARE RECKLESS, BIASED, AND IRRESPONSIBLE. Your statement carries weight purely because of your "Dr" in front of your name. For god's sake, your a freaking radiologist who went to a bio-identical hormone seminar, and suddenly became an "expert": god bless america. You speak of the financial motives: oh yes, you clearly are above such influences. You are a hippocrate.

      A few case reports does not make a study. If there appears to be a link, then it should be, and is being, investigated. However the fact remains that bisphosphonates are beneficial to humanity, especially those with osteoporosis and thus at tremendously high risk of both vertebral compression fractures and femur neck (hip) fractures.

      Your statement is analogous to me saying bioidentical hormones such as estradiol causes fatal blood clots, strokes, heart attacks, and breast cancers and should be banned by the FDA. Though the side effects are real, they are relatively rare and the bad does not necessarily outweigh the good.

      S.Lynch MD

      PS: "Bio-identical" Estradiol is $4 per mth at Walmart: ask your "tainted" main-stream doctor for a prescription today and skip your trip to the "hollywood radiologist bio-identical specialist".

      • Jeffrey Dach MD says:

        Dear Dr Lynch,

        Perhaps you should also be calling insanely irresponsible the 2010 AAOS meeting which presented studies from the Hospital for Special Surgery (HSS) and Columbia University Medical Center which showed that Fosamax disturbs bone formation, and implicated Fosamax in spontaneous mid-femur fractures.

        Perhaps you should also be calling reckless, biased and irresponsible Clarita Odvina MD who reported nine cases of spontaneous femur fracture on Fosamax. Or Dr. Goh, a doctor in Singapore, who identified nine more cases in his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term Fosamax. Or Joseph M Lane MD who reported 15 cases of spontaneous femur fracture in women on Fosamax with a unique radiographic pattern.

        Rather, I would say it is insanely irresponsible for any caring physician to give a drug that causes spontaneous mid femur fractures, jaw necrosis, and diffuse bone and joint pain.

        You don't need a double blind placebo controlled study to show a drug disturbs bone physiology. The histology slides don't lie.

        Conflict of interest? That is a laugh. Drug companies clean up on Fosamax,a 3 billion dollar industry. Now that kind of money can generate a real conflict of interest, documented by Aubrey Blumsohn MD who blew the whistle on the Actonel studies.

        jeffrey dach md

      • Cecelia Tkach says:

        Dr. Lynch:
        I am not a medical doctor, nor do I have any scientific experience. I am an MBA student; and, from all the research I have done on Merck & Co., it is obvious what has become of this company. It has placed many lives in jepordy (over 28,000 died from taking Vioxx); never mind people who fall and break a bone (I am not being unsympathetic).

        However, if a company who knew prior to its release that people could die from taking Vioxx; then, they surely do not care that some people break a bone. Dr. Dach is correct in that the pharmaceutical industry benefited tremendously from the passage of Bayh-Dole Act (1980) and Hatch-Waxman Act (1984).

        These two Acts have made the pharmaceutical industry the richest companies in the world; and sadly, the FDA catered them them, especially Merck & Co. To bad we can't get rid of the FDA, maybe so many lives would have not been lost due to their neglect and turning the other way.

  16. steve livermore says:

    My wife just went through this issue. Broken right femur just below the hib joint. The Hell she went through can not be described. Surgery…4 hours. Now therapy/rehab. She has stopped the fosamax after hearing the report given by Diane Sawyer and has an appointment with her regular doctor late this week. Being a vetern and in that system, she talked with her Vetern Doctor and that doctor knew nothing about the report. While on the phone she read the article on the computer and admitted that she, as a doctor, knew nothing of any issues until reading this. Log us in as one of many. We are praying for the ladies who will yet experience what my wife just went through.

  17. Peter Stone says:

    How's this for a headline: FDA Fingers Fosamax For Femur Fractures!

    • Carmen Berger says:

      I am replying for my wife – She has been taking fosomax for approx 7 years until

      two years ago she broke her left femur by bending over during some work in

      the home.Following recovery she discontinued taking the medication.The doctor

      did not advise to the contrary. I would appreciate info on further dvelopments in

      this very important in this matter. Thanks.

    • Carolyn says:

      In June 2008 I tripped on a chair and fell breaking my right femur. I was taking Fosamax and had been for approximately 15 years. In June 2009 my left femur broke while walking downstairs and holding on to a rail. At that time, I was immediately taken off Fosamax by my surgeons at the San Francisco General Hospital. Once I returned home to Florida, my endocrinologist prescribed Forteo for me. I have a rod and screws in both legs.

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