Many lawsuits have been filed recently by people who used Fosamax to treat their osteoporosis, but later found that Fosamax has damaged their bone health. These unexpected adverse effects have most frequently surfaced as problems in the jaw bone or the femur.
Fosamax is a drug that reduces the chance of having a hip or spinal fracture. It has become the drug of choice for doctors who want to prescribe something for the prevention of osteopenia, a precursor to osteoporosis. Osteopenia is the word used to describe loss of bone density.
The term ‘osteopenia’ became popular in medical literature about the same time as the drug Fosamax came into the open market. Osteopenia is a condition characterized by lower than normal bone mineral density (BMD), where the BMD is not low enough to be classified as osteoporosis. In patients with osteopenia there is a greater risk that as time passes, they may develop osteoporosis. Bones naturally become thinner as people grow older and the existing bone cells are reabsorbed by the body faster than new bone is made. A common consequence of porous bones is fractures. Although osteoporosis is often considered to be a woman’s disease, osteoporosis also affects many men. This condition results in brittle bones owing to the loss of calcium and other mineral components, sometimes resulting in pain, decreased height, and skeletal deformities. It is also associated with long-term steroid therapy and certain endocrine disorders.
To address these common problems, doctors have long sought an effective treatment or a means of preventing such conditions from ever developing. Pharmaceutical companies have also tried to develop a cure. Fosamax, also known as alendronic acid or alendronate sodium, is one such drug and is famous for the dramatic results it produces. But, like all drugs, Fosamax too has side effects. The only difference is, its side effects are disastrous and the losses it causes are irreversible.
As a result, thousands of lawsuits are filed against Merck — the company that produces and markets Fosamax. It has been alleged by the claimants that Fosamax when taken by osteoporosis patients has been found to result in low-stress femur fractures and ONJ (osteonecrosis of jaw).
More and more research is being conducted on the link between Fosamax and these side effects, and many case studies have been published that illustrate the problem. However, there are some differences of opinion among the researchers about exact mechanism that causes the link. Nonetheless, this research and these studies are being used in an increasing number of Fosamax cases filed against Merck. Many of these lawsuits seek compensation for atypical subtrochanteric femoral shaft fractures, commonly known as femur fractures.
In May 2011, Journal of Bone and Mineral Research published an article- ‘Oral bisphosphonates and risk of subtrochanteric or diaphyseal femur fractures in a population-based cohort’. This study was designed to compare the relative risks of the drugs commonly prescribed to treat osteoporosis. An abstract from the article says: “There was no evidence of an increased risk of subtrochanteric or diaphyseal femur fractures in bisphosphonate users compared with raloxifene/calcitonin users. However, this study cannot exclude the possibility that long-term bisphosphonate use may increase the risk of these fractures.” Thus, the study was inconclusive on the key issue of causation.
Bisphosphonate Use and Atypical Fractures of the Femoral Shaft is a a large Swedish cohort study, which was published by The New England Journal of Medicine in May 2011. The study found that the risk of femoral shaft fractures increased 50 times with the use of bisphosphonates for treating osteoporosis like Fosamax (alendronate), although the absolute risk of developing a femur fracture, remained very small. This study should enable plaintiffs in the Fosamax lawsuits to meet their burden of proof, which requires evidence that the relative risk at least doubled from the use of the drug.
Some recent medical research regarding bisphosphonate-related osteonecrosis of the jaw also gives some interesting findings. To date, there is no direct study that proves oral biophosphonates increase the risk of ONJ. However, there is a new study confirming that there is a six-times increase in risk for ONJ among patients who receive the same drug in intravenous form. This important bisphosphonate study was published in Abstract 890 of Medscape for ‘International Association of Dental Research, at 89th General Session and Exhibition in March 2011.’
In February 2011, the Journal of Dental Research published another study: ONJ in Two Dental Practice-Based Research Network Regions. In this study, ONJ was found to be linked with the use of all biosphosphonates, including Fosamax (alendronate). This article concluded that patients who had used oral bisphosphonates were 15.5 times more likely to have ONJ than those who had not — although the absolute risk for ONJ from oral bisphosphonates is low.
These scientific studies are key pieces of the evidence that will be used to pursue claims for the users of Fosamax who suffered these devastating and debilitating adverse side effects. If you or a loved one have suffered from a femor fracture or ONJ after taking Fosamax, please fill up the case evaluation form.