FOR A FREE CASE EVALUATION, CALL 1-800-632-1404

A History

On October 13, 2010, the Food and Drug Administration (FDA) revised the warning label for Fosamax and other bisphosphonates warning of the ”risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis.”  Atypical subtrochanteric femur fractures ( fractures in the bone below the hip joint) and diaphyseal femur fractures (fractures in the long part of the thigh bone) are rare but have been predominantly linked to patients taking bisphosphonates. A study released in the March 20, 2010 issue of the New England Journal of Medicine found that women on long-term Fosamax use suffered an unusually high rate of femur fractures. The fractures had a signature horizontal pattern and all occurred as a result of falls from standing height or less. The study, conducted by the Hospital for Special Surgery at Weill Cornell Medical College in New York City, included fifteen women who were on Fosamax more than five years before their femur fracture. Two-thirds of the women studied had taken Fosamax for seven years or longer.

The study’s authors theorize that Fosamax slows down the development of strong new collagen or causes microdamage in the bone, making its users more prone to fracture. The FDA issued an alert to physicians in January 2010 regarding the possibility of severe bone pain related to bisphosphonate therapy. The authors reportedly plan to analyze their findings in a prospective study.

Fosamax and ONJ

ONJ is a painful and disfiguring condition resulting from infection of the jaw and exposed portions of bone inside the mouth, causeing the jaw bone to decay and die. Symptoms may take weeks or months to become evident and may develop following trauma to the tooth, such as an extraction or other dental surgery that exposes jaw bone. While almost all cases of ONJ have occurred following dental work, several cases have been reported as having occurred in the absence of dental work when bone is exposed and subject to infection.

Fosamax History and Potential Dangers

The FDA approved Fosamax tablets on September 29, 1995 and the oral solution on September 17, 2003. Fosamax is in the non-nitrogenous class of bisphosphonates, meaning it contains a nitrogen atom. Other drugs within this class, such as Aredia® and Zometa®, are used in chemotherapy but are not indicated for use in non-cancerous conditions like osteoporosis.

Throughout the 1990s and 2000s, medical articles and studies reported the frequent and common occurrence of ONJ following the use of nitrogenous bisphosphonates used for chemotherapy. Because Merck reported and acknowledged Fosamax side effects concerning irritation, erosion, and inflammation of the upper gastrointestinal tract, we believe this manufacturer knew or should have known that Fosamax, as a nitrogenous bisphosphonate, shared an adverse event profile similar to that of the other drugs within this specific subclass of bisphosphonates.

In addition, our Fosamax lawyers believe that Merck knew or should have known that bisphosphonates also inhibit the development of blood vessels in an organism or tissue of an affected area, resulting in an inadequate supply of blood, specifically to patients’ lower jaws and upper jaws. As a result, a minor injury or disease can turn into a non-healing wound that may then progress to widespread bone death and inflammation of bone marrow.

An article about bisphosphonate-associated osteonecrosis of the jaw in the Oregon Dental Association’s March 2006 newsletter cites an increasing number of complications associated with the use of bisphosphonate drugs and specifically names Fosamax as being associated with development of a disorder involving non-healing, necrotic exposure of bone in the jaws. The article uses the term bisphosphonate-associated osteonecrosis of the jaw (BONJ).

Some state dental associations are now advising dentists to refrain from using any invasive procedure, such as drilling a cavity, on any patients who are taking Fosamax. Once osteonecrosis begins and becomes symptomatic, it is very difficult to treat and is not reversible.

On January 7, 2008, the FDA issued an alert regarding the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. The alert said that severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate.

Help for those injured by Actonel, Boniva, Fosamax, Reclast and Zometa

Bisphosphonates are used to treat osteoporosis in men and women. On March 11, 2010, the FDA issued a MedWatch alert regarding another injury related to bisphosphonates: “atypical subtrochanteric femur fractures.” The FDA is conducting an ongoing review of the possible connection between bisphosphonate use and femur fracture risk, which are fractures in the bone just below the hip joint. Manufacturers are Merck (Fosamax), Proctor & Gamble/Sanofi (Actonel), Roche (Boniva) and Novartis (Reclast and Zometa).

You may have sustained femur fracture, which is specifically being referred to as “low-energy”, meaning they are apparently happening in a fall from a “standing height or less”–such as stepping down stairs. The nature of this fracture is what makes it “atypical”, and is also referred to as “spontaneous” in certain instances.

The FDA has made it clear that it this point, it has not found a clear connection between bisphosphonate use and a risk of unusual femur fractures. The FDA intends to use the expertise of outside experts such as members of the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force. ABC News recently reported that patients who take these drugs for more than five years can suffer from spontaneous bone fractures. There has also been an alleged link between the drugs and severe musculoskeletal pain, as well as to a severe bone-related jaw disease called osteonecrosis.

In 2008, bisphosphonate sales surpassed $3.5 billion according to data supplied by from IMS Health. There were over 37 million prescriptions were written for the osteoporosis medication Fosamax in 2008. If you have sustained a similar injury, you should contact us for a free case evaluation:

What should you do?

If you have used Actonel, Boniva, Fosamax, Reclast and Zometa and have fractured your femur, you should consult your prescribing physician as soon as possible, if you have not already done so.

Should you contact an attorney?

If you have used Actonel, Boniva, Fosamax, Reclast and Zometa and have fractured your femur you should contact an attorney immediately for review of a potential claim against the manufacturer. Statutes of limitation, which are deadlines set by state law, regulate the filing of lawsuits, and they vary from state to state. If the statute of limitations in your state expires, your right to pursue a claim against the manufacturer may be forever barred. If you or a loved one was harmed by Actonel, Boniva, Fosamax, Reclast and Zometa®, you should not delay in contacting an attorney

We are here to help.

Tim Edwars and Ed Wallis are attorneys currently representing clients who have taken several prescription drugs and claim injuries associated with those drugs, including Wellbutrin®, Yaz®, Accutane® and Reglan®. They also represents clients across the globe pertaining to medical device failures, including the Advanced Bionics HiRes90k® cochlear implant and the Gynecare Prolift® transvaginal mesh – sling. For a free case evaluation, please contact:

CALL US TOLL FREE: (800) 632-1404

EMAIL: click here

FILL OUT THIS FORM: