Fosamax, A Bad Drug In Litigation by Jeffrey Dach MD

No Bullshit Fosamax Actonel BonivaFosamax for Pre-Osteoporosis, A Bad Idea
by Jeffrey Dach MD

A number of patients have recently told me their primary care doctors started them on Fosamax for "pre-osteoporosis" a condition less severe than full blown osteoporosis, also called "osteopenia".  This is a very bad idea.

Two Problems Here

Problem One: The Fosamax (Alendronate) medical study for FDA approval failed to show any benefit for the osteopenia group.  Fracture rates actually went up for the osteopenia group.  This data was published by Cummings in JAMA in 1998 (the FIT study, which stands for Fracture Intervention Trial).

Problem Two: Bisphosphonates drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous femur fracture, atrial fibrillation (a heart rhythm disturbance), and severe bone and joint pain.  Another common adverse effect is esophageal erosion, heartburn and esophageal reflux.

A few definitions: Osteoporosis is defined as a DEXA T-Score of  minus 2.5 to minus 3.5.  Pre-osteoporosis is defined as a DEXA T-Score of minus 2.0 to minus 2.5.

Fosamax, A Bad Drug in Litigation

How to Recognize a Bad Drug?

One of the early warning signs of a bad drug is ongoing drug litigation for adverse side effects.  This calls the drug into question as a "BAD DRUG".

Fosamax drug litigation began this month (Aug 2009) against Merck by plaintiff, Shirley Boles, age 71, who suffered ONJ (osteonecrosis of the jaw) allegedly from Fosamax.  OJN, osteonecrosis of the jaw, is a well known adverse side effect of Fosamax, which has been heavily documented in the dental and oral surgery medical literature.  Merck faces an onslaught of more than 900 cases awaiting litigation.

Fosamax Induced Femur FractureSpontaneous Femur Fracture Induced by Fosamax

Another warning sign of a BAD DRUG is spontaneous femur fractures (with no trauma) that occur in women on Fosamax.  A number of these embarrassing reports have appeared in the  New England Journal of Medicine and the Orthopedic Surgery medical literature.

FDA Warning of Fosamax Induced Bone and Joint Pain

Another sign of a BAD DRUG is an FDA Warning letter.   Physicians received such a warning letter telling then about severe, incapacitating  bone and joint pain caused by Fosamax.  What causes this ? No answer there.  I would suggest multiple micro-fractures as the cause for the severe bone pain. 

Left Image: Spontaneous femur fracture on Fosamax, courtesy of Dr Lane and NEJM.

Consumer Complaints Against Fosamax

Another warning sign of a bad drug is the number of consumer complaints on message boards which can be seen by anyone with an internet connection.

Why is Fosamax a BAD Drug ?

Dexa Scan Table Jeffrey Dach MDThere is no question that follow up DEXA BONE SCANS show improving bone density on Fosamax.  So why is this a bad drug?

The answer is this increased bone density is cosmetic and does not equate with stronger bone. Simply put, the drug creates pathologic bone that is weak and brittle. The fosamax treated bone is actually more prone to spontaneous fracture and necrosis, not less so.  The drug actually does the reverse of what it is intended for.

left image: Dexa Scanner courtesy of wikimedia commons

Reverse Osteoporosis Naturally-Our Program

Rather than use a bad drug like Fosamax, a far better solution for reversing osteoporosis is a combined program of lifestyle modification, diet, nutrition, exercise and bio-identical hormone supplementation.

1) Modify diet to an alkaline diet which halts calcium loss as a buffering agent for acid excretion.  Use home pH testing to determine success.
2) Nutritional supplement with high quality calcium product containing bioavailable calcium, magnesium, boron, strontium, and Vitamin K.
3) Test for and optimize Vitamin D and Magnesium levels.
4) Regular Weight bearing exercise program as tolerated.
5) Test for and optimize hormone levels for estradiol, progesterone, testosterone, and DHEA.

LAtest Update: Fosamax Trial Ends in Mistrial Sept 22 2009.

Links to Related Content

Fosamax Induced Femur Fractures by Jeffrey Dach MD

Bisphosphonates for Osteoporosis, A Closer Look at the Data by Jeffrey Dach MD

Fosamax, Actonel, Osteoporosis and Toulouse Lautrec by Jeffrey Dach M.D.

Osteoporosis web page on jeffrey dach md Web site

Links and References

http://www.newsinferno.com/archives/2326
Actonel, Fosamax, other Osteoporosis Drugs Draw FDA Pain Warning
Date Published: Monday, January 7th, 2008

Actonel, Fosamax and other anti-osteoporosis drugs known as bisphosphonates have been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain, the Food & Drug Administration (FDA) warned today.  Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the FDA said that the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and impairment, and necessitating the use of analgesics.

Bisphosphonate, sold under the brand names Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa,  are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women.

According to today’s FDA warning, the severe musculoskeletal pain associated with bisphosphonates may occur within days, months, or years after starting a bisphosphonate.  Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution.

Bisphosphonates have been linked to a variety of other safety problems.  In October, the FDA announced that it was reviewing the drugs after studies showed patients taking bisphosphonates ran a higher risk of irregular heartbeat. 

Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

Fosamax has also been linked to Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.

http://www.theage.com.au/world/down-to-the-bone-20090807-ecwy.html
Down to the bone RAY MOYNIHAN August 8, 2009

http://www.fiercepharma.com/story/bellwether-fosomax-trial-starts-today/2009-08-10

Bellwether Fosamax trial starts today August 10, 2009 — 10:35am ET | By Tracy Staton. 

Merck faces some 900 lawsuits over claims that the drug causes a painful and irreversible decay of the jawbone. In this first case, Shirley Boles, 71, claims that Fosamax caused her osteonecrosis of the jaw--essentially, death of jawbone tissue--and that Merck knew about the risks as early as 1996.   

http://www.bloomberg.com/apps/news?pid=20601103&sid=aN.O.OLorMnc

Merck Faces First Trial of Claim That Fosamax Attacks Jawbone By Thom Weidlich and Margaret Cronin Fisk Bloomberg News

Aug. 10 (Bloomberg) -- Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial tomorrow in a case that may affect all the others. The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three so-called bellwether cases that may point the way to out-of-court settlements.

Merck faced about 900 Fosamax cases as of June 30, including suits with multiple patients, the company said in an Aug. 3 regulatory filing. Whitehouse Station, New Jersey-based Merck, which is buying rival Schering-Plough Corp., had a reserve of about $42 million for the litigation, including lawyers’ fees, it said. It hasn’t set aside any money to pay damages, it said.

There are as many as 1,200 plaintiffs in state and federal cases, Merck says. Timothy O’Brien, a lawyer representing about 400 plaintiffs, said the number is closer to 2,000.

Sales of Fosamax last year, when the drug first faced U.S. generic competition, fell by half to $1.55 billion from $3.05 billion in 2007. Sales fell 44 percent to $261.3 million in this year’s first quarter, Merck reported in April.

http://www.youhavealawyer.com/blog/2008/08/21/fosamax-lawsuits-pile-up/

1. Terejimenez Says: About one year and a half ago, I took Fosamax for 3 months during which I was severely sick and it was me who discovered that Fosamax was causing my pain in the joints, bones, face. I was in physical therapy , visited several doctors from several disciplines and no one could give me a diagnose . I am self employed and was unable to work for several weeks because I was seriously sick. After I decided to stop taking Fosamax I began to recover without any medicines and a week later I was the same I had been before, no pains, no sickness, no fever, no fatigue.

2. Diana Says: I took fosomax for three years and stopped when i finally realized that the pain in my muscels began after i started taking fosomax. Before fosomax I had no pain , I exercised at the gym almost every day and I felt great. I was 65 and the doctor put me on fosomax, after a few months I began to have a lot of pain, could hardly get out of bed because of pain, standing or sitting it did not make any difference. When I quit I could hardly walk any more because of the pain in my seat, lower back and legs. I am 71 and my muscels still react with pain if I exercise. I am very angry when I think about having taking fosomax when I felt so great and painless and now i still have times of pain mostly walking. I don’t walk like I should or exercise be cause it iritates my back, hips and leg muscles.

Fosamax Lawsuits Continue to Pile Up Against Merck  August 21st, 2008 by Austin Kirk

According to a report published last week by Lloyds Corporate Litigation Reporter, Merck & Co., Inc. faced approximately 655 Fosamax lawsuits involving over 1,000 plaintiff groups as of June 30, 2008. The lawsuits were filed on behalf of users who have suffered a disfiguring jaw condition, known as osteonecrosis of the jaw, and other side effects related to the oosteoporosis drug.

http://www.consumeraffairs.com/rx/fosamax.html 
consumer complaints about Fosamax

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/
ucm124165.htm

FDA Warning Letter on Fosamax


Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood Fl 33021
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Comments
Page: 1 of 1
  • 09-03-2009 Michelle wrote:
    Dear Dr Dach,

    I've had to have a lot of dental work recently. I've noticed that dentists now have added "Do you take bisphosphonates such as Fosamax, (Actonel, Boniva ?" in their questionnaires. I've told the dentists that I have osteopenia but refused to take biophosphonates.

    Their reactions? "Good. Those are really bad drugs."
     
    Michelle
    _________________________________________________________

    Thanks for the comment, Michelle.

    Here is the ADA report of Dental Management of patients on bisphosphonates.

    Migliorati CA, Casiglia J, Epstein J, et al. Managing the care of patients with bisphosphonate-associated osteonecrosis: a American Academy of Oral Medicine position paper. J Am Dent Assoc 2005;136:1658-68 .



    Jeffrey Dach MD  www.drdach.com   disclaimer

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  • 09-21-2009 KL from Orlando wrote:
    Comments : Dear Dr. Dach,

    Thank you for all the information posted on your website.

    I found the site while doing a google search for using strontium in the treatment of osteoporosis. I don't have osteoporosis yet, but I do have some bone loss after having a complete hysterectomy nine years ago. I believe there are other contributing factors but I won't go into all that right now. I've been doing a lot of research regarding the treatment of bone loss without the use of drugs such as Fosamax. I'm only 43 years old and do not like the long-term risks associated with those types of medications.

    I've been interested in bio-available HRT for some time now but currently don't have the financial means to pursue that option, as I don't believe it would be an option using a Medicare insurance plan. I plan on getting back to work within a year and at that time will be very interested in becoming a patient - I'm not that far from you as I live in Orlando. Until that time, I am very pleased that you have chosen to share such a good amount of information.

    Again, thank you so much for all the wonderful information and I look forward to meeting you at some point in the not-so-distant future.

    Regards,

    KL from Orlando

    Reply to this
  • 09-22-2009 Anne Cranshaw wrote:

    Anyone interested in natural alternatives to bisphosphonates needs to research the work of Dr. Narain Naidu. He is the scientist who solved the problem of toxic shock syndrome and was nominated for a Nobel Prize in 2004 for his work on using lactoferrin to kill e-coli. Whenever you eat a hamburger, you are benefiting from his work.

    He has been studying lactoferrin for over 20 years and the results of his double-blind, randomized, placebo controlled study was published in the January 2009 issue of Osteoporosis International.

    His lactoferrin product for bone health showed up to 10% increase in new bone growth in six months or less!

    This is considered impossible in the traditional medical community. There are no negative side effects as lactoferrin is a natural substance produced by our body to support many organ functions. As we age, less is available for our use and symptoms may present. A large pharmaceutical company offered Dr. Naidu $70 million for his patent but he turned it down because he believed they would "sweep it under the rug" and not bring it to market. People who are healthy do not generate income for them.

    Anne Cranshaw
                         _________________________________________________________
                    disclaimer

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  • 02-11-2010 Carrie wrote:
    Hi Dr Dach,

    I just want to thank you for your website and the information you've made available.

    I am a 49-year-old nonsmoking, small-framed woman just diagnosed with osteopenia (T score, -1.125).

    I went through menopause at age 44-45 and did not take HRT.

    My doctor is recommending Boniva or Actonel, probably for the rest of my life! There has to be another way! I am searching for alternatives and am trying to inform myself about this condition.

    I am VERY grateful for the articles, books, and links you have provided. Many thanks!!

    Carrie from GA
    _________________________________________________________
      disclaimer

    Reply to this
  • 03-22-2010 BH wrote:
    Dr Dach,

    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 along with the fear of this happening again - I will be very interested in the final findings.

    BH
    _________________________________________________________
    disclaimer

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  • 03-22-2010 GB wrote:
    Reclast has been recommended for my Down Syndrome 55 year old cousin. have great conserns about necrosis of the jaw. She cannot exercise and we have her on Bone Guard (Perque), Strontium and Veal Bone powder. If this does not show improvement does anyone have any other thoughts? Thanks.

    GB
    _________________________________________________________
    disclaimer

    Reply to this
  • 03-27-2010 Kathryn J. foster wrote:
    I took fosamax for 10 years. After over eight years on it I had pain in my right thigh. it broke while I was standing still. I continued the fosamax until the same thing occured the following year to my left thigh. Now I believe, after many test to rule out any other cause, that fosamax made my bones break.
    Reply to this
  • 07-26-2010 KF wrote:
    Dr Dach,

    After my comment concerning Fosamax and its horrid results in my life, I am more convinced than ever that its long-term use should be banned.

    After the two broken femurs and two surgeries, my health is returning to somewhat normal. But it still upsets me to realize that my case has gone unacknowledged by my personal doctor who put me on it, and insisted I remain on it past the time when it did do some good for lower back discomfort.

    I have not returned to his office since Feb. /10... just days before the second femur snapped while I was standing still. At that time I had been using a cane for months and still being diagnosed with bursitis.

    It was ignorance on the doctor's part I'm sure, as he was shocked to read the article I showed him that day about Fosamax and thigh fractures. Although he told me to discontinue Fosamax, (I already had done this, a week or so before my last doctor's visit) I learned that he did not alert his other patients on the drug to the dangers of its long-term use.

    Keep up your good work of warning about this dangerous drug.


    from KF

    _________________________________________________________


    Thanks KF, for sharing your experience with others,

    regards from
    Jeffrey Dach MD 
    www.drdach.com  
    disclaimer

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  • 01-18-2013 KF wrote:
    Dear Dr Dach,

    My long term use of Fosamax, over 10 years ruined both of my femurs and has caused much pain.

    KF
    --------------------------------------------------------------------

    Hi KF,

    Thanks for reporting your experience with Fosamax.
    warmest regards,

    Jeffrey Dach MD
    www.drdach.com
    disclaimer

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