Related Topics: Bioidentical Hormones, Features, Osteoporosis

Fosamax, A Bad Drug In Litigation by Jeffrey Dach MD

The drug of choice by many physicians for osteoporosis it is now being prescribed for pre-osteoporosis (osteopenia). This is a bad idea and here he explains exactly why, and that bioidentical natural hormones are a much better answer.

Dr Jeffrey Dach

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 with two problems.

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).

The FIT data revealed that Fosamax (Alendronate) doubled the risk of hip fractures in women with a femoral neck T score greater than -2.5.  There were 6 hip fractures (0.4%) in the placebo group vs. 11 fractures (0.8%) in the Fosamax group.

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 oesophageal erosion, heartburn and oesophageal 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

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 in 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.

Spontaneous 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 Orthopaedic 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.

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 ?

There 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.

Reverse Osteoporosis Naturally

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 that 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.

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Please feel free to discuss this article in the comments section below, but note that the author cannot respond to queries made there.
 
Comments 3
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M. T. D., Ph.D. | 9:19 pm, May 8th, 2012

Dear Dr. Dach,
You are spreading fear in a dangerous manner about a medication that has helped many millions of patients around the world…yes, there are side effects and they are real but what you fail to point out is that these numbers are exceedingly small compared to the efficacy seen in reducing fracture risk.
Also, you have some plain facts wrong: Osteoporosis is defined as having a T-Score of -2.5 or less, and or having a fragility fracture of the spine and or hip. Secondly, there is no such thing as preosteoporosis…the term is osteopenia. Depending on the level of bone strength (BMD) and it’s subsequent statistical analysis (T-Score) a patient may be treatable. A tremendous tool called FRAX has been available for more than 4 years which allows for defining an individuals risk for fracture in the next ten years…such tools are used to choose which patient in the osteopenic range may be helped by the armament of meds now available…not just Fosamax (alendronate).
Of course. all your “natural reversal” facts are a given for slowing or maintaining bone mass, but in people at high risk for fracture none of them are effective in reversing bone loss or strenthening bone.
Please stop fear mongering… it only adds fuel to the fire of class action lawyers waiting for the next opportunity and waste of court time which would be better spent on Wall Street Criminals.

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Viky | 3:00 am, June 3rd, 2012

Hello, My story is the same as so many ohetrs you have heard. To be as breif as I can, I am 48 and have been rnnuig for about 4 years on and off, mostly 3-4 mile 4-5 days a week. Last year I became more serious and ran 2 -1/2 marathons as well as completed the 9 races in NYC to qualify for the marathon in 09. As luck would have it, I was also excepted in 08 s marathon. I began training and by mid july last year I was diagnosed with a stress fracture(after being told it was only a shin splint). I was up to 18 miles at that time and the pain grew so that I could not proceed. I took off a few months, and did not do the 08 marathon. Now it is 09, I saw a specialist and I was dianosed with a soft arch bought very expensive orthodics and began to slowly train. Around my 10 mile long run, the same pain reoccured in the same spot on the same leg. I went back to the Doc, and he gave me an injection to relieve the inflamation and made a minor adjustment to my orthodics. I believe it is broke again by the feel, but not sure I really want a 3rd bone scan or MRI in 18 months to prove it. Can I cross train with a bike, and wear a brace so I can contnue to run this fall? I think iif I cross train, and only run 18 once, then 20 once I should be able to do 26. Please help

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AnnA Rushton | 7:10 pm, June 3rd, 2012

Sorry Vicky but we are not experts in marathon training but if you feel you have again damaged your let then you really do need to both res it and go back for medical advice. We suggest you go back and get the bone scanned for osteoporosis and if that is the case then a supplemental regime of bioidentical natural progesterone could help.

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