Why has the FDA moved so slowly on this issue. Bisphosphonates as a class of drugs should be taken off of the market immediately.
Fosamax and femur fractures : FDA is investigating possible links
By Mary Rice Tuesday, March 9th, 2010
Original Source: http://personalmoneystore.com/moneyblog/2010/03/09/fosamax-and-femur-fractures-fda-investigating/
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.
Comments
Patricia O’Dea says: April 24, 2010 at 6:05 am
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!
Jeffrey Dach MD says: March 23, 2010 at 3:53 pm
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
Linda Blackburn says: March 23, 2010 at 5:37 am
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.
Jeffrey Dach MD says: March 22, 2010 at 5:21 pm
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
Bonnie Hay says: March 22, 2010 at 7:59 am
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.
Jorge Anglin says: March 18, 2010 at 6:36 pm
I am truly appalled it is absurd that nothing has been done about this drug that has been allegedly linked to causing 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
Terri Lewis says: March 12, 2010 at 11:43 am
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!!
Jeffrey Dach MD says: March 11, 2010 at 4:21 am
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: March 16, 2010 at 8:45 pm
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: March 22, 2010 at 5:20 pm
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
steve livermore says: March 10, 2010 at 12:47 pm
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.
Peter Stone says: March 9, 2010 at 3:40 pm
How’s this for a headline: FDA Fingers Fosamax For Femur Fractures!
Reply Carmen Berger says: April 26, 2010 at 9:04 am
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 developments in
this very important in this matter. Thanks.
Patricia O’Dea says: April 24, 2010 at 6:05 am
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!
Jeffrey Dach MD says: March 23, 2010 at 3:53 pm
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
Linda Blackburn says: March 23, 2010 at 5:37 am
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.
Jeffrey Dach MD says: March 22, 2010 at 5:21 pm
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
Bonnie Hay says: March 22, 2010 at 7:59 am
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.
Jorge Anglin says: March 18, 2010 at 6:36 pm
I am truly appalled it is absurd that nothing has been done about this drug that has been allegedly linked to causing 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
Terri Lewis says: March 12, 2010 at 11:43 am
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!!
Jeffrey Dach MD says: March 11, 2010 at 4:21 am
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: March 16, 2010 at 8:45 pm
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: March 22, 2010 at 5:20 pm
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
steve livermore says: March 10, 2010 at 12:47 pm
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.
Peter Stone says: March 9, 2010 at 3:40 pm
How’s this for a headline: FDA Fingers Fosamax For Femur Fractures!
Reply Carmen Berger says: April 26, 2010 at 9:04 am
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 developments in
this very important in this matter. Thanks.