Fosamax linked to Femur, Hip, Shoulder, and Knee fractures and Osteonecrosis of the Jaw (ONJ), which may lead to painful repair surgeries and partial or full Jaw removal
Fosamax, also known as Alendronic acid or alendronate sodium, is a drug prescribed for the purpose of increasing bone density in patients with osteoporosis or at high risk for osteoporosis. Patients are generally menopausal women because they are at a markedly high risk for osteoporosis. Fosamax was originally produced by Merck & Co starting in October 1995 and was approved by the FDA for the treatment of osteoporosis. As of 2005, more than 20 million people are estimated to have taken Fosamax , which is now Merck’s best selling drug.
Purported as the essential “bone-builder”, Fosamax has been heavily promoted to pre-menopausal women who fear hip fractures and bone density tests. Merck ‘s initial advertising included women in their mid 40s who aimed to prevent the development of osteoporosis or fractures.
In 2004, the FDA began to issue warnings about the potential link between Fosamax and Osteonecrosis of the Jaw (known as ONJ). ONJ is a painful disease linked to pain, swelling, and infection in the jaws, loss of teeth, and the partial or complete loss of the jaw bone. While there were several studies linking Fosamax to ONJ, Merck did not acknowledge the link between the two until March of 2010, citing ONJ as a rare “Adverse reaction” to Fosamax.
In 2008, researchers at Cornell University reported that Fosamax patients were more than 125 times more likely to develop femur fractures than patients who had not taken Fosamax. Later research found that Fosamax patients were more likely to develop fractures in other parts of the body such as the hip, shoulder and knee. On March 8, 2010, ABC World News Tonight aired a special on individuals who’d taken Fosamax for extended periods of time and developed fractures. As of March 2010, the FDA has been looking into the linkage between Fosamax and bone breaks, but has yet to establish a clear connection.
As of 2011, there were approximately 1000 Fosamax lawsuits filed throughout the United States.
Fosamax is part of a family of drugs known as “bisphosphonates”, which are prescribed specifically to treat osteoporosis in post-menopausal women. Merck’s Fosamax and Procter and Gamble’s Actonel are the two most common oral versions of bisphosphonates. When ingested, Fosamax works by rapidly partitioning and binding to exposed bone areas, with 50% binding to exposed surfaces and the rest being exposed by the kidneys. While Fosamax was marketed as a “bone builder”, it is easier to think of Fosamax as a “Bone hardener” making the outide of bones rigid, while the entire may be hollow or decaying. Inasmuch as Fosamax, moves to exposed bone surfaces very quickly, bone tissue damage and normal bone wear does not heal as normal. Instead, the exterior is hardened and the interior may still be unhealed, infected or hollow- leading to an increased risk for fracture, breaking, and deterioration. Once in the system, Fosamax has a very long “Half-Life” and remains in the body for up to 10 years. As a result, long term use has often been linked to permanent decay.
While Merck maintains that Fosamax is not dangerous and that there is no “causal link” demonstrated between long term use of Fosamax and bone fractures, a further look at Merck’s test data shows that their tests have been primarily limited to patients who used Fosamax for less than three years. There have been several studies that directly contradict Merck’s finding and suggest that long term use increases the likelihood of bone fracture. Data suggests that 1/2000 Fosamax patients experience a femur fracture and even more patients experience bone fractures in other places.
Research also shows that there are a great deal of patients who are prescribed Fosamax as a pre-ventative osteoporosis measure and that patients who have not actually developed osteoporosis should not be taking Fosamax, especially in the long term. Patients who take Fosamax as a preventive measure have been shown to be at a much higher risk for femur fratures and ONJ. Research presented to the American Academy of Orthopedic Surgeons in 2010 concluded that bone quality decreased when Fosamax was used in periods of more than 3 years.
In addition to ONJ and bone fractures, the New England Journal of Medicine reported a link be-tween the use of Fosamax an the incidence of Esophageal Cancer. Further, Recent studies at the Harvard University School of Dental Medicine conclude that between six to ten percent of cancer patients are likely to develop ONJ. Hence, cancer increases one’s risk of ONJ.
Osteonecrosis of the Jaw (ONJ):
- Pain, Swelling, and Infection(osteomyelitis) in the gums
- Loosened Teeth
- Lost Teeth
- Poor dental and gum healing
- Numbness and “heaviness” in the jaw
- Partial loss of the Jaw
- Complete loss of the Jaw
- Broken Femur/ Thigh bones
- Fractured Femur/Thigh bone
- Severe pain or swelling around the Thigh
Osteonecrosis (bone damage) and Osteomyelitis (infection) may also occur in the following places:
- The Hip
- The Knee
- The Shoulder
- Osteoporosis Drugs, Like Fosamax May Increase Risk of Broken Bones in Some Women- 03/08/2010
- Fosamax Side Effects Can Be Life Threatening- 06/27/2011
- FDA Panel to discuss Safety of Osteoporosis Drugs- 07/08/2011
- Possible Increased risk of Certain types of Thigh Bone Fractures with Long-term Bisphosphonates Use
- Bisphosphonate-Induced Exposed Bone( Osteonecrosis/Osteopetrosis) of the Jaws: Risk Factors, Recognition, Prevention, and Treatment
- Some Patients using Fosamax over the Long-Term May be at Risk for One Type of Fracture