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RISK INCREASES WITH USE LONGER THAN 3 YEARS

Studies are showing that there is a definite risk, and some patients have an even higher risk than others. In particular, patients who have taken Fosamax for five years or longer are the most at risk. Patients who have taken Fosamax for at least three years, plus another type of bisphosphonate (such as Actonel, Boniva or Aredia) for at least two years, are also at a higher risk. Click here for a more detailed list.


Bisphosphonate Class Drugs

Brand Name

Chemical Name

Manufacturer(s)

Fosmax

Alendronic Acid

Aledronate Sodium

Merck

TEVA Pharmaceuticals; Mylan; Watson Pharmaceuticals; Apotex; Dr. Reddys Laboratories, Ltd; Aurobindo Pharma; AustarPharma LLC; Cadista Pharmaceuticals; Cadista Pharmaceuticals

Boniva

Ibrandronic Acid

Ibrandronate Sodium

Glaxo SmithKline & Roche

Actenol

Risedronate Sodium

Risodronic Acid

Mascot Health

Forteo

Teriparatide

Eli Lilly & Company

Aredia

Pamidronic Acid

Pamidronate Sodium

Novartis

Protelos

Protos

Strontium Renelate

Servier

Reclast

Zoledronic Acid

Zoledronate Sodium

Novartis

"MY LEG JUST SNAPPED"

The fractures caused by Fosamax are usually "low impact" or "no impact" fractures. Some patients report actually feeling the bone break before they hit the floor. As an example, one woman states, "I thought I slipped and fell, but I really felt the bone snap before I went down. It was like the bone broke and that is actually what caused me to fall." Another example is a woman who was wading in water who was struck at thigh level by the wake of a small boat, causing the bone to snap. These are examples of the "low impact" or "no impact" fractures occurring in some women taking Fosamax long term.

FDA WARNS OF RISK WITH LONG TERM USE

The FDA (Food and Drug Administration) has recently required the manufacturers to make a "SAFETY LABEL CHANGE" specifically warning about the increased risk of atypical fractures and advising prescribers on revised risk evaluation and mitigation strategies. Click here to read the FDA safety labeling change and REMS notification.

SIGNATURE INJURY – WHY FOSAMAX BREAKS ARE DIFFERENT

The other classic finding in femur fractures caused by Fosamax is the atypical area where the fracture, or "break", occurs. Most femur fractures, that is most typical femur fractures occur in the femoral neck or trochanteric region. Atypical femur fractures occur in the subtrochanteric region. The fractures may also have a stress fracture appearance when not resulting in a complete break.

BLOCKS THE BODY'S NATURAL BONE HEALING

The scientific thought behind the development of atypical fractures after extended use of Fosamax is as follows:

Fosamax eventually slows the remodeling of bone to the point the remodeling process effectively stops. "Remodeling" is the process by which the body "takes up", or absorbs, old bone and then new bone is "laid down", or created, in its place. This natural cycle is the process the body employs to maintain healthy bone and make repairs to damaged bone. When this "remodeling" is halted, the old bone is not replaced or repaired. Any areas of stress fracture simply continue to develop and over time the major break / fracture then occurs.

RISK vs. BENEFIT

The manufacturer of Fosamax, Merck Pharmaceuticals, will increasingly advocate studies that tend to downplay the risk of these fractures. Several studies, listed below, still show an increased risk even though they have taken the position that the risk is small and benefits outweigh the risks.

Fortunately for the injured patients, even studies driven by pharmaceutical companies are showing the increased risk, such as a recent study in the New England Journal of Medicine, "Bisphosphonate Use and Atypical Fractures of the Femoral Shaft" (Schilcher, et al.; N Engl J Med 2011), which was sponsored in part by the drug company Eli Lilly. Because the bones do become increasing brittle with age, the drug manufacturers are compiling evidence that will make it more difficult to prove that these fractures, especially in women 80 years of age and older, were due to Fosamax. Click here for more information.


Some of the currently "pharmaceutically driven" published articles:

New England Journal of Medicine "Bisphosphonate Use and Atypical Fractures of the Femoral Shaft" was sponsored in part by the drug company Eli Lily.
(Jörg Schilcher, M.D., Karl Michaëlsson, M.D., Ph.D., and Per Aspenberg, M.D., Ph.D.
N Engl J Med 2011; 364:1728-1737/May 5, 2011)

New England Journal of Medicine "Bisphosphonates and Fractures of the Subtrochanteric or Diaphyseal Femur" was sponsored in large part by Merck, the maker of Fosamax.
(Dennis M. Black, Ph.D., Michael P. Kelly, M.D., Harry K. Genant, M.D., Lisa Palermo, M.A., Richard Eastell, M.D., Christina Bucci-Rechtweg, M.D., Jane Cauley, Ph.D., Ping Chung Leung, M.D., Steven Boonen, M.D., Ph.D., Arthur Santora, M.D., Anne de Papp, M.D., and Douglas C. Bauer, M.D. for the Fracture Intervention Trial and HORIZON Pivotal Fracture Trial Steering Committees
N Engl J Med 2010; 362:1761-1771/May 13, 2010)

HOW WE CAN HELP

At the law office of Brad Bradshaw M.D. J.D., we have extensive background, experience and results in medical legal cases. Why should you choose our firm to represent you? We are working on Fosamax cases throughout the United States, with lawyers in various jurisdictions, and seeking to obtain what we believe are the best locations to pursue cases for both settlement and litigation. We work with other law firms to try and maximize our clients' recoveries. Additionally, we have successfully litigated and settled other cases involving hip injuries, specifically the defective Sulzer Hip replacements. We also assisted with some cases involving the defective DePuy Hip replacement. Dr. Bradshaw recently litigated an individual truck wreck case that involved a hip injury and back injury resulting in a total recovery of just under $900,000. If you would like for us to consider your case, please call us toll free at 888-775-0000. To expedite review of your potential case, complete the questionnaire by clicking here. Please wait at least 15 minutes after submitting the questionnaire before contacting our office. Be sure and let us know if you completed the questionnaire. Read an unsolicited letter from a client to find out more!

Disclaimer: Information on this website and other web pages is of a general nature only. The information is not specific to any particular chase and may not apply to your case. Dr. Bradshaw's office will be working with and referring cases to other attorneys, and in particular attorneys in California. Statutes and other information listed on this site may not be current as laws are constantly changing. There are almost always exceptions to general principles of law. This site does not contain legal advice and should not be used as such. This site is primarily designed so that you might ask more educated and important questions when you contact a qualified attorney. Retain a qualified attorney for legal representation or legal advice as soon as possible. Almost all cases require legal analysis by a qualified attorney. This website conforms to the ethical rules of Missouri, which is the principle location of practice where Dr. Bradshaw's license is continually active and where all permanent staffed offices are located. When working on cases outside the state of Missouri, a co-counsel, often called local counsel, will be hired. This even applies to states in Dr. Bradshaw is licensed to practice law. Dr. Bradshaw is not certified by the Texas Board of Legal Specialization. The choice of a lawyer is an important decision and should not be based solely upon advertisements. Meetings with lawyers will be by appointment only. Past results afford no guarantee of future results and every case is different and must be judged on its own merits. Some photos and scenes may depict simulations. Client may be responsible for costs or expenses in some cases.